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GRMGlobal Regulatory Monitor English 이번 주 소식

최근 규제 소식

주간 브리프에 싣지 않은 규제기관·업계 단체의 최근 소식을 날짜순으로 모았습니다.

이번 주 브리프 보기 주간 브리프 아카이브

2026-11-09 주

2026-11-13
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2026
EMA
2026-11-13
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - List of medically important (MI) VeDDRA terms
EMA
2026-11-13
Determination That DIBENZYLINE (Phenoxybenzamine Hydrochloride) Oral Capsule, 10 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
미국 관보
2026-11-13
Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages; Confirmation of Effective Date
미국 관보
2026-11-13
[HC] SECARIS NASAL GEL: Affected lot may contain foreign matter
캐나다 보건부 회수
2026-11-13
의약외품의 점자 표시 등에 대한 가이드라인
식약처
2026-11-13
「바이오의약품 원료물질 및 원료의약품의 수입절차 특례 등에 관한 규정」 제정고시안 행정예고(식품의약품안전처 공고 제 2026-553호)
식약처
2026-11-12
GMP & GDP Forum 2027 in Berlin: Exhibition & Sponsorship Opportunities
ECA Academy
2026-11-12
Hong Kong Implements GDP Guide for Pharmaceutical Products
ECA Academy
2026-11-12
Oversight of Cross-Border Online Pharmacies and Compliance with GDP Requirements
ECA Academy
2026-11-12
USP <1079.5>: USP Publishes Responses to Comments
ECA Academy
2026-11-12
Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
미국 관보
2026-11-12
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Qualified Importer Program
미국 관보
2026-11-12
Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry; Availability
미국 관보
2026-11-12
Patient-Level Data for Drugs and Biological Products Submissions Containing Real-World Data and Real-World Evidence; Request for Information
미국 관보
2026-11-12
Hematology and Pathology Devices; Reclassification of Immunohistochemistry Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
미국 관보
2026-11-12
Class 4 Medicines Defect Notification: Star Pharmaceuticals Ltd, Enalapril maleate/ Hydrochlorothiazide 20 mg/12.5 mg Tablets, EL(26)A/48
영국 MHRA
2026-11-12
Revision of the PIC Scheme (PIC/S 1/95 (Rev. 7))
PIC/S
2026-11-10
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability
미국 관보
2026-11-10
Color Additive Petition From Environmental Defense Fund et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene
미국 관보
2026-11-10
Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and…
미국 관보
2026-11-09
Cross-Contamination: The Particular Risk Posed by Beta-Lactam Antibiotics
ECA Academy
2026-11-09
EMA Procedural Advice Updates: Centralised Procedure
ECA Academy
2026-11-09
FDA Cites Airflow, Aseptic Conditions and Visual Inspection at Korean Manufacturer
ECA Academy
2026-11-09
FDA Updates how it Evaluates and Inspects Human Drug Facilities
ECA Academy
2026-11-09
FDA Warning Letter to US based Manufacturer: Sterile Manufacturing Failures
ECA Academy
2026-11-09
Revision of USP Chapter <1033> on the Validation of Bioassays
ECA Academy
2026-11-09
Single-Temperature Incubation in Ambient Monitoring – Is it Permissible and Advisable?
ECA Academy
2026-11-09
Draft guideline on predictive biomarker assays in the context of medicinal product lifecycle
EMA
2026-11-09
Draft guideline on risk assessment of medicinal products in human reproduction and breastfeeding: from data to product information - Revision 1
EMA
2026-11-09
[HC] PDP-DIPHENHYDRAMINE 25 MG and 50 MG CAPSULES: Out-of-specification (Impurity)
캐나다 보건부 회수
2026-11-09
Expanding the Pharmaceutical Quality Framework: Part 1 - Leveraging AI-Derived Insights Across CMC, Process Validation, and Quality Systems
ISPE
2026-11-09
「생물학적제제 기준 및 시험방법」 일부개정고시(안) 행정예고 알림(공고 제2026-547호, 2026.11.9.)
식약처

2026-11-02 주

2026-11-06
Food Additive Petitions; Change of Address
미국 관보
2026-11-06
Quality Unites: Building Community Beyond Compliance: Why Quality Needs Communities More Than Ever
ISPE
2026-11-06
연조직고정용장치 허가·심사 가이드라인
식약처
2026-11-06
「의약품 등의 허가 등에 관한 수수료 규정」 일부고시개정(안)(공고 제2026-544호, 2026.11.6.)
식약처
2026-11-06
첨단바이오의약품 안전 및 지원에 관한 규칙 일부개정령(안) 입법예고 알림(공고 제2026-533호)
식약처
2026-11-05
Eurachem Publishes Webinar Recording on the Fitness for Purpose of Analytical Methods Guide
ECA Academy
2026-11-05
Meet the AQCG Board Members at PharmaLab 2026
ECA Academy
2026-11-05
Recent Publications Highlighting Topics to be Discussed at PharmaLab 2026
ECA Academy
2026-11-05
매개변수기반 출하 적용 의약품 품질심사 질의응답집
식약처
2026-11-05
「임상시험용의약품 표시 등에 관한 규정」 제정고시(안) 행정예고(식품의약품안전처 공고 제2026-540호)
식약처
2026-11-05
Class 3 Medicines Recall: Aspire Pharma Limited, Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml , EL(26)A/47
영국 MHRA
2026-11-05
Class 4 Medicines Defect Notification: Sandoz Limited, Co-Amoxiclav powder for oral suspension 250/62.5 mg/5mL, EL(26)A/46
영국 MHRA
2026-11-04
Beyond Human-in-the-Loop: Can Machine-in-the-Loop Address Coverage Failure in GxP Validation?
ISPE
2026-11-04
Abiraterone Acetate Tablets USP 500 mg, 60-count bottles, Rx only, Distributed by: Glenmark Pharmaceuticals USA, Elmwood Park, NJ 07407, NDC 68462-882-60
FDA 회수
2026-11-04
Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash, Net Contents: 1 Gallon (3.8 L), Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, 30013, UPC 711808198393
FDA 회수
2026-11-04
Aerocare Sani Mango Antiseptic Hand and Body Wash, Net Contents: 1 Gallon (3.8 L), Manufactured By: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA 33013, UPC 711808198249
FDA 회수
2026-11-04
Antiseptic Hand Soap, Net Contents: 1 Gallon (3.8 L) Distributed By: image supply, inc., P.O. Box 1108, 5081 Dawn Drive, Lumberton, NC28359
FDA 회수
2026-11-04
Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL Laboratories Private Limited, Telangana - 509228, India; Distributed by: Novadoz Pharmaceuticals LLC…
FDA 회수
2026-11-04
Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers, 0.02 FL OZ (0.5 mL) each, Manufactured by: Huons Co., Ltd, Jecheon-si, Chungcheongbuk-do, 27159, South…
FDA 회수
2026-11-04
Certus Medical Satin Foam, 750 ml (25.4 fl. oz.), Manufactured for: Cartus Medical, 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808250930
FDA 회수
2026-11-04
Chemseptic, Net Contents: 1 Gallon (3.8 L), Distributed By: RMC Rochester Midland Corporation, 155 Paragon Drive, Rochester, NY 14624 USA, Made in USA
FDA 회수
2026-11-04
Delta Foremost Sani-Foam Mango, Net Contents: 1000 ML, 33.8 FL OZ, Manufactured Expressly For: Delta Foremost Chemical Corp., 3915 Air Park Street, Memphis, TN 38118,
FDA 회수
2026-11-04
Formoterol Fumarate Inhalation Solution, 20mcg/2mL, packaged in cartons of 30 individually wrapped vials (NDC 76204-030-01) and 60 individually wrapped vials (NDC 76204-030-02), Rx only, Manufactured…
FDA 회수
2026-11-04
Freshhands Premium Foamy Antibacterial Hand Soap Antiseptic, Net Contents: 18 oz (532 mL), Sold By; Consolidated Chemicals, LLC, 3191 W Tharpe St. Tallahassee, FL 32303 USA, UPC
FDA 회수
2026-11-04
Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash, Net Contents : 18oz (532ml), Sold by, Momar Incorporated, 1880 Ellsworth Industrial Drive, N.W., Atlanta, Georgia, 80818.
FDA 회수
2026-11-04
Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534, NDC 72189-0211-50
FDA 회수
2026-11-04
Lynx, LX0864 peachy-foam antiseptic handsoap, 1000 ML (33.8 FL OZ.) Manufactured by: ABC Compounding Co., INC., 2500 Dogwood Dr., Conyers, GA 30013, UPC 711808210804.
FDA 회수
2026-11-04
Lynx, antibacterial hand soap, Net Contents 1 Gallon, (3.8 L), Manufactured by: ABC Compounding Co., INC., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808199925.
FDA 회수
2026-11-04
Lynx, antibacterial hand soap, Refill, Net Contents 1 Gallon, (3.8 L), Manufactured by: ABC Compounding Co., INC., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808200027.
FDA 회수
2026-11-04
Metoclopramide Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 51079-886-20.
FDA 회수
2026-11-04
OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985203050. NDC…
FDA 회수
2026-11-04
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg, packaged as a) 30-count bottle, NDC 33342-246-07; b) 90-count bottle, NDC 33342-246-10; Rx Only, Manufactured for…
FDA 회수
2026-11-04
PHENYLephrine HCL Infusion, 100 mg per 250 mL in 0.9% Sodium Chloride (0.4 mg/mL), Sterile, Rx Only, Single-Use Container, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL…
FDA 회수
2026-11-04
PRO CHEM BAN AID, Antiseptic Hand Soap, Net Contents: 1 GALLON (3.8 L), Sold by: PRO CHEM, Inc.,1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004.
FDA 회수
2026-11-04
PRO CHEM Fresh Start, Antibacterial Hand Soap, Antiseptic Hand Soap, 800mL bag, Sold by: PRO CHEM, Inc.,1475 Bluegrass Lakes Parkway, Alpharetta, GA 30064.
FDA 회수
2026-11-04
Palm Antiseptic Hand Soap Net Contents: 1 Gallon (3.8 L). Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808196498
FDA 회수
2026-11-04
People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash, NET CONTENTS: 1000 ML 33.8 FL OZ, Distributed by: People's Janitorial Supply, 955 Main Street, Forest Park, GA 30298, 404-363-2226.
FDA 회수
2026-11-04
Pro Chem Suds Hand Soap, Net Contents: 18 OZ (532 ml), Sold by Pro Chem Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004
FDA 회수
2026-11-04
Spurrier, Antimicrobial Hand Soap, Net Contents: 1 Gallon (3.8 L), Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013, UPC 726133100508
FDA 회수
2026-11-04
SunCoast Paper Inc. Surgent Antiseptic Hand Soap, Net Contents : 1 Gallon (3.8 L), SunCoast Paper In., 4111 Community Rd., Brunswick, GA 31520, UPC 654441P10219
FDA 회수
2026-11-04
Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10
FDA 회수
2026-11-04
Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.
FDA 회수
2026-11-04
ULTRA STRENTGH, ELECTRIC MIDICATED BALM (menthol 16% and methyl salicylate 32%) packaged in a) Net 2.45 oz (70g) (NDC 63299-001-01) and b) 10g (NDC 63299-001-02), Manufactured by Fei Fah Medical Mfg…
FDA 회수
2026-11-04
Wechem Hand Guard8/1000mL Bag, Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013
FDA 회수
2026-11-04
ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0
FDA 회수
2026-11-04
Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-744-11
FDA 회수
2026-11-04
Vecuronium Bromide for Injection, 20mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-745-21
FDA 회수
2026-11-04
Tridacaine III / Lidocaine Patch 5%, 15 envelopes containing 1 patch each per pouch, Rx only, Distributed by: Trifluent Pharma San Antonio, TX 78213, NDC 73352-835-15.
FDA 회수
2026-11-03
QRD Appendix V - Adverse-drug-reaction reporting details
EMA
2026-11-03
Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability
미국 관보
2026-11-03
Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability
미국 관보
2026-11-03
[HC] ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL and Potential Bag Leaks
캐나다 보건부 회수
2026-11-03
How Hepalink's FOYA-Winning Pingshan Facility Uses Artificial Intelligence (AI), 5G, and Automation to Improve Sterile Manufacturing
ISPE
2026-11-02
FDA Warning Letter: When Test Procedures Allow Retesting Until an Acceptable Result is Obtained
ECA Academy
2026-11-02
Failed GMP Training in 2026: Further GMP Training Deficiencies in FDA Warning Letters
ECA Academy
2026-11-02
New Version of VDI Guideline 2083 Sheet 15
ECA Academy
2026-11-02
PIC/S publishes a Q&A document to assist with Annex 1
ECA Academy
2026-11-02
Reprotoxic and Persistent: ECHA Committee Recommends New Classification for TFA
ECA Academy
2026-11-02
Singapore Added to the List of Recognised third Countries for Importation of APIs
ECA Academy
2026-11-02
Infant Formula Nutrient Requirements
미국 관보
2026-11-02
[HC] Cyclophosphamide for Injection USP: Presence of particulate matter
캐나다 보건부 회수
2026-11-02
제네릭의약품 품질심사 주요 보완사례집
식약처

2026-10-26 주

2026-10-30
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 - 29 October 2026
EMA
2026-10-30
List of centrally authorised products with safety-related changes to the product information
EMA
2026-10-30
Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Third Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation…
미국 관보
2026-10-30
Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability
미국 관보
2026-10-30
[HC] Equate Ultra Strength Antacid Chewable Tablet: may contain foreign matter (metal fragments)
캐나다 보건부 회수
2026-10-30
Beyond the Dashboard: Bringing Visual Intelligence to Pharma Operations
ISPE
2026-10-30
바이오 무균의약품 제조 규정 적용 사례집
식약처
2026-10-30
오가노이드 기반 세포치료제의 임상시험 시 품질 및 비임상 평가 가이드라인
식약처
2026-10-30
의약품의 점자표시 등에 대한 가이드라인
식약처
2026-10-30
일본뇌염 백신 품질평가 가이드라인
식약처
2026-10-30
한약(생약)제제 GMP 질의응답집(민원인 안내서)
식약처
2026-10-30
환자경험자료에 기반한 의약품 허가심사 가이드라인
식약처
2026-10-30
희귀질환 대상 유전자치료제 개발 시 품질, 비임상 및 임상 평가 고려사항
식약처
2026-10-30
디지털융합의약품 심사 업무절차서
식약처
2026-10-30
의약품등 회수·폐기 처리 운영 지침
식약처
2026-10-30
「의약품의 품목허가·신고·심사 규정」 일부개정 고시 알림
식약처
2026-10-30
「한약(생약)제제 등의 품목허가·신고에 관한 규정」 일부개정고시(식품의약품안전처 고시 제2026-73호)
식약처
2026-10-29
EMA closed on All Souls' Day, 2 November
EMA
2026-10-29
From Concept to Production: Lessons from Productionizing AI in Pharmaceutical Manufacturing
ISPE
2026-10-29
동등생물의약품 평가 가이드라인
식약처
2026-10-29
박테리오파지 치료제의 임상시험 시 품질 및 비임상 평가 가이드라인
식약처
2026-10-29
한약(생약)제제 벤조피렌 안전성 평가 및 자료작성 방법
식약처
2026-10-29
의약품등 품목별 사전 GMP 평가 운영지침
식약처
2026-10-29
「희귀의약품 지정에 관한 규정」 일부개정고시(안)(공고 제2026-522호, 2026.10.29.)
식약처
2026-10-29
'의약외품 품목허가·신고·심사 규정' 일부개정고시
식약처
2026-10-29
Class 2 Medicines Recall: Accord-UK Ltd, Lercanidipine Hydrochloride 10mg Film-Coated Tablets, EL(26)A/45
영국 MHRA
2026-10-29
Class 2 Medicines Recall: Advanz Pharma Limited, Mynzepli 40 mg/mL solution for injection in pre-filled syringe, EL(26)A/44
영국 MHRA
2026-10-28
Notice to sponsors on validation and qualification of computerised systems used in clinical trials
EMA
2026-10-28
Notice to sponsors on validation and qualification of computerised systems used in clinical trials
EMA
2026-10-28
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs
미국 관보
2026-10-28
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
미국 관보
2026-10-28
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys
미국 관보
2026-10-28
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification
미국 관보
2026-10-28
Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability
미국 관보
2026-10-28
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability
미국 관보
2026-10-28
의약품 허가·심사 세부업무방안 등의 관리 매뉴얼
식약처
2026-10-28
Six months of progress under the UK’s new clinical trials regulations
영국 MHRA
2026-10-28
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1…
FDA 회수
2026-10-28
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1…
FDA 회수
2026-10-28
Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.
FDA 회수
2026-10-28
ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item #…
FDA 회수
2026-10-28
ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786…
FDA 회수
2026-10-28
Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO…
FDA 회수
2026-10-28
Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in paper cartons, Rx only, Manufactured for AvKARE, Pulaski, TN 38478, NDC 50268-037-15.
FDA 회수
2026-10-28
Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC…
FDA 회수
2026-10-28
BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC…
FDA 회수
2026-10-28
BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodium monofluorophosphate 0.76%) Cool Mint, 2 Value Pack, Two 3.5 oz (99g) tubes, Total Net Wt 7 oz (198g), Distributed by…
FDA 회수
2026-10-28
Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC…
FDA 회수
2026-10-28
Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761…
FDA 회수
2026-10-28
Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California…
FDA 회수
2026-10-28
Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761…
FDA 회수
2026-10-28
Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761…
FDA 회수
2026-10-28
Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761…
FDA 회수
2026-10-28
Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC…
FDA 회수
2026-10-28
Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario…
FDA 회수
2026-10-28
Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761…
FDA 회수
2026-10-28
Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC…
FDA 회수
2026-10-28
Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California…
FDA 회수
2026-10-28
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC…
FDA 회수
2026-10-28
Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885. Carton NDC: NDC 81952-111-06, Vial NDC…
FDA 회수
2026-10-28
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.
FDA 회수
2026-10-28
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10
FDA 회수
2026-10-28
Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials ( NDC 73271-1226-2) This Is A Compounded Dug, Intramuscular Use, Office Use Only, 8400 Esters Blvd…
FDA 회수
2026-10-28
evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-886-19…
FDA 회수
2026-10-28
evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC…
FDA 회수
2026-10-28
Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.
FDA 회수
2026-10-28
Adoption and Entry into force of PIC/S Recommendation (PI 058-1) - Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022)
PIC/S
2026-10-27
Draft Reflection Paper on Drug Interactions of Herbal Medicinal Products
ECA Academy
2026-10-27
EMA Updates User Manual for XEVMPDweb
ECA Academy
2026-10-27
FDA Warning Letter for a microbially contaminated Sterile Solution
ECA Academy
2026-10-27
Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
미국 관보
2026-10-27
U.S.-Origin Statements on Seafood; Draft Guidance for Industry; Availability
미국 관보
2026-10-27
From Documents to Records to Intelligence: The Next Digital Frontier in Life Sciences
ISPE
2026-10-27
의약품동등성시험 가이드라인
식약처
2026-10-26
EMA and CMDh Expand List of Nitrosamine Limits
ECA Academy
2026-10-26
Inadequate Supplier Oversight and missing Tests: Lessons from an FDA Warning Letter
ECA Academy
2026-10-26
Survey Results on the Use of AI in Equipment Qualification
ECA Academy
2026-10-26
Class 2 Medicines Recall: Xeal Pharma, Clopidogrel Oral Liquids (all strengths), EL(26)A/43
영국 MHRA

2026-10-19 주

2026-10-23
AMA and EMA issue joint guidance on Ebola vaccine development
EMA
2026-10-23
Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products
미국 관보
2026-10-23
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products
미국 관보
2026-10-23
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program
미국 관보
2026-10-23
Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO
미국 관보
2026-10-23
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability
미국 관보
2026-10-23
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
미국 관보
2026-10-23
‘의약외품 범위 지정 검토위원회 구성 및 운영에 관한 규정’제정안 행정예고(식품의약품안전처 공고 제2026-507호)
식약처
2026-10-21
Guidance on good manufacturing practice and good distribution practice: Questions and answers
EMA
2026-10-21
Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability
미국 관보
2026-10-21
[HC] Femyso: Affected lot may contain two green Mifepristone cartons or two pink Misoprostol cartons instead of one of each.
캐나다 보건부 회수
2026-10-21
의약외품 반창고의 기준 및 시험방법 작성을 위한 가이드라인
식약처
2026-10-21
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc…
FDA 회수
2026-10-21
Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11
FDA 회수
2026-10-21
Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05
FDA 회수
2026-10-21
Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
FDA 회수
2026-10-21
Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
FDA 회수
2026-10-20
ICH publishes Online Training Materials for ICH E6(R3) Good Clinical Practice
ECA Academy
2026-10-20
New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Availability
미국 관보
2026-10-19
Aseptic Manufacturing with significant Deficiencies - FDA criticises Monitoring, RABS and Media Fills
ECA Academy
2026-10-19
BP Publishes new Draft Texts
ECA Academy
2026-10-19
Differing Assessments within a Company are a poor Basis for an FDA Inspection
ECA Academy
2026-10-19
EMA Clarifies ESMP Reporting for Critical Medicine Shortages
ECA Academy
2026-10-19
EMA Updates Information Page on Bioequivalence Guidelines
ECA Academy
2026-10-19
FDA Cites Serious CGMP Deficiencies at Stream2Sea
ECA Academy
2026-10-19
FDA Identifies Critical Deficiencies in Analytical Testing and CGMP Oversight
ECA Academy
2026-10-19
IPEC Publishes Version 3 of the Excipient Composition Guide
ECA Academy
2026-10-19
Sterile means Sterile
ECA Academy
2026-10-19
Switzerland: GMP Compliance by Foreign Manufacturers
ECA Academy
2026-10-19
Draft Data Quality Framework (DQF) for EU medicines regulation: application to collection, management and submission of Adverse Drug Reaction reports
EMA
2026-10-19
Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics
EMA
2026-10-19
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/CHMP/29947/2013/Rev.4)
EMA
2026-10-19
Reflection paper on methodological aspects in confirmatory platform trials
EMA
2026-10-19
[HC] Dantrium Intravenous (Dantrolene sodium for injection): Presence of particulate matter
캐나다 보건부 회수

2026-10-12 주

2026-10-05 주

2026-10-09
Annual report of the Pharmacovigilance Inspectors Working Group for 2025
EMA
2026-10-09
Questions and answers on the PIP compliance verification procedure at EMA, and on paediatric rewards
EMA
2026-10-09
Questions and answers on the PIP compliance verification procedure at EMA, and on paediatric rewards
EMA
2026-10-09
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements
미국 관보
2026-10-09
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
미국 관보
2026-10-09
Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams
미국 관보
2026-10-09
Challenges and Solutions in Lot-Level Food Traceability; Public Meeting
미국 관보
2026-10-09
Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
미국 관보
2026-10-09
Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC
미국 관보
2026-10-09
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction
미국 관보
2026-10-09
Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications
미국 관보
2026-10-09
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability
미국 관보
2026-10-08
Clinical trial applications advice pilot becomes permanent
EMA
2026-10-08
Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products
EMA
2026-10-08
Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked…
미국 관보
2026-10-08
Antibody-Drug Conjugate (ADC) Cleaning Validation: How to Evaluate Degradation, Select Analytical Methods, and Reduce Validation Risk
ISPE
2026-10-07
Analytical Quality Group Developments May through August 2026
ECA Academy
2026-10-07
Validation Group Update May-August 2026
ECA Academy
2026-10-07
Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
미국 관보
2026-10-07
Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel…
FDA 회수
2026-10-07
Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63
FDA 회수
2026-10-07
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
FDA 회수
2026-10-07
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.
FDA 회수
2026-10-07
FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19
FDA 회수
2026-10-07
Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC…
FDA 회수
2026-10-07
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
FDA 회수
2026-10-07
Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield…
FDA 회수
2026-10-06
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
EMA
2026-10-06
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
EMA
2026-10-06
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
EMA
2026-10-06
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
EMA
2026-10-06
Concept paper on the guideline revision on good pharmacogenomic practice
EMA
2026-10-06
Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information
미국 관보
2026-10-06
Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or…
미국 관보
2026-10-06
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction
미국 관보
2026-10-06
[HC] Carvedilol 25 mg Tablets: Out-of-specification (Impurity)
캐나다 보건부 회수
2026-10-06
[HC] PMS-Carvedilol 25 mg Tablets: Out-of-specification (Impurity)
캐나다 보건부 회수
2026-10-06
From Digital Transformation to Human-Centric Manufacturing: Designing Collaborative Workspaces for the Future of Pharma
ISPE
2026-10-05
CEP 2.0: EDQM Updates Guidance on the Use of Certificates of Suitability
ECA Academy
2026-10-05
EDQM Updates Guidance on CEP Sister File Applications
ECA Academy
2026-10-05
FDA: Next Step to Reduce Animal Based Testing Methods
ECA Academy
2026-10-05
Pharmeuropa: Revision Proposed for Chapter 2.5.32 on Coulometric Karl Fischer Water Determination
ECA Academy
2026-10-05
Two New FDA Warning Letters Put OOS Investigations in Focus
ECA Academy
2026-10-05
USP Revises the Pharmaceutical Water Monographs
ECA Academy
2026-10-05
[HC] Carvedilol 25 mg Tablets: Out-of-specification (Impurity)
캐나다 보건부 회수
2026-10-05
[HC] PDP-DIPHENHYDRAMINE 25 MG CAPSULE: Out-of-specification (Impurity)
캐나다 보건부 회수
2026-10-05
From Science to Systems to Patients: Key Insights from the 2026 ISPE Annual Meeting & Expo Chairs
ISPE
2026-10-05
The Second Question
ISPE
2026-10-05
Class 3 Medicines Recall: Norgine Limited, MOVICOL Plain 13.7g powder for oral solution, EL(26)A/41
영국 MHRA

2026-09-28 주

2026-10-02
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October
EMA
2026-10-02
동등생물의약품 심사 검토서 작성 요령
식약처
2026-10-01
Advice on ‘end-of-year’ submission dates for type I variations in 2026
EMA
2026-10-01
EMA Management Board: highlights of September 2026 meeting
EMA
2026-10-01
Executive Director speech at EMA women’s health multi-stakeholder workshop
EMA
2026-10-01
Global regulators call for advancing alternatives to animal testing across the medicine lifecycle
EMA
2026-10-01
Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal
미국 관보
2026-10-01
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal
미국 관보
2026-10-01
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program
미국 관보
2026-10-01
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
미국 관보
2026-10-01
Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees
미국 관보
2026-10-01
How Pharma 4.0™ Supports Inspection-Ready Compliance at the 2026 ISPE Pharma 4.0™ and Biopharma Conference
ISPE
2026-10-01
Will EU GMP Annex 22 Include Grandfathering for Legacy Artificial Intelligence Systems? Lessons from 21 CFR Part 11
ISPE
2026-10-01
의약품 시판 후 개별 사례 보고 관리 가이드라인
식약처
2026-10-01
Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
영국 MHRA
2026-10-01
WHO PQT launches eCTD submissions through the ePQS Portal
WHO
2026-09-30
GDP Non-Compliance Report: CAPA Measures must not only be Promised but also Implemented
ECA Academy
2026-09-30
USA: Court Stops Warehouse Activities Following Persistent Insanitary Warehouse Conditions
ECA Academy
2026-09-30
Version 4.0 of the Swissmedic Document on Notifications of Changes Published
ECA Academy
2026-09-30
Warehouse Temperature Excursions: What Does the FDA Expect?
ECA Academy
2026-09-30
Women are missing from medicines development: EMA’s roadmap for change
EMA
2026-09-30
Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
미국 관보
2026-09-30
Annex 1 and Global Harmonization on Aseptic Filling: Insights from the 2026 ISPE Aseptic Conference Regulatory Panel
ISPE
2026-09-30
바이러스 표적 단클론항체의약품 및 기타 치료용 단백질의 역가시험법 개발 시 고려사항
식약처
2026-09-30
소기업·연구개발자를 위한 알기 쉬운 제품화 가이드(의약품, 의료기기, 임상통계 분야)
식약처
2026-09-30
의약외품 표시 광고 가이드라인
식약처
2026-09-30
의약품 품목 갱신 업무 민원인을 위한 가이드라인
식약처
2026-09-30
의약품의 위해성 관리 계획 가이드라인
식약처
2026-09-30
한약(생약)제제 품질심사 주요 보완사례집
식약처
2026-09-30
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN…
FDA 회수
2026-09-30
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15
FDA 회수
2026-09-30
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc…
FDA 회수
2026-09-30
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech…
FDA 회수
2026-09-30
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213…
FDA 회수
2026-09-30
Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC…
FDA 회수
2026-09-30
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City…
FDA 회수
2026-09-30
Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38
FDA 회수
2026-09-30
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC…
FDA 회수
2026-09-30
Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.
FDA 회수
2026-09-30
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci…
FDA 회수
2026-09-30
Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.
FDA 회수
2026-09-30
Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC…
FDA 회수
2026-09-30
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh…
FDA 회수
2026-09-29
Can Cannabis Flowers be pre-dried in Accordance with GACP?
ECA Academy
2026-09-29
FDA wants to Advance the Development of Herbal Medicinal Products
ECA Academy
2026-09-29
Ph. Eur. Draft for Comment: 2.8.18. Determination of Aflatoxin B1 in Herbal Drugs
ECA Academy
2026-09-29
Water Determination in Herbal Drugs
ECA Academy
2026-09-29
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling)…
미국 관보
2026-09-29
Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
미국 관보
2026-09-29
FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters
미국 관보
2026-09-29
생균치료제 제조시설 운영 관리 지침
식약처
2026-09-28
Cleaning Validation in the Manufacture of non-sterile Medicinal Products: new Information from the EMA
ECA Academy
2026-09-28
EMA publishes final ICH M13B Guideline and Q&A on Bioequivalence
ECA Academy
2026-09-28
FDA Warning Letter: Deficiencies in Impurity Testing, Stability, OOS Investigations and Temperature Control
ECA Academy
2026-09-28
New Japanese Pharmacopoeia Drafts (September 2026) Open for Public Comment
ECA Academy
2026-09-28
The Relationship between the BP and the Ph. Eur.
ECA Academy
2026-09-28
[HC] PMS-FAMPRIDINE 10 mg Tablet: Affected lot may contain foreign material particles.
캐나다 보건부 회수
2026-09-28
변경관리 계획서 자료 검토에 관한 업무
식약처

2026-09-21 주

2026-09-25
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application (NDA) 219694 for Atropine Sulfate Ophthalmic…
미국 관보
2026-09-25
Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
미국 관보
2026-09-25
Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good…
미국 관보
2026-09-25
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
미국 관보
2026-09-25
[HC] Limited number of Sarclisa single use vials may have been frozen during shipment
캐나다 보건부 회수
2026-09-25
[HC] Sanofi-Aventis Canada Inc. recalling certain insulin pens and cartridges
캐나다 보건부 회수
2026-09-24
INS-GCP-1 procedure for coordinating good-clinical-practice inspections requested by the CHMP
EMA
2026-09-24
INS-GCP-1 procedure for coordinating good-clinical-practice inspections requested by the CHMP
EMA
2026-09-24
Draft guideline on the clinical requirements for medicines intended for the treatment of sickle cell disease
EMA
2026-09-24
Draft guideline on the clinical requirements for medicines intended for the treatment of thalassaemia
EMA
2026-09-24
Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information
미국 관보
2026-09-24
[HC] Apo-Semaglutide Injection : Incorrect dose display
캐나다 보건부 회수
2026-09-23
의료제품 개발 상담 사례집(의약품, 바이오의약품, 의료기기)
식약처
2026-09-23
Class 4 Medicines Defect Notification: B. Braun Melsungen AG, Meropenem 1000 mg powder and solvent for solution for infusion, EL(26)A/39
영국 MHRA
2026-09-23
Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830…
FDA 회수
2026-09-23
Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
FDA 회수
2026-09-23
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.
FDA 회수
2026-09-23
Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
FDA 회수
2026-09-23
Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
FDA 회수
2026-09-23
Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
FDA 회수
2026-09-23
Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
FDA 회수
2026-09-23
Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
FDA 회수
2026-09-23
Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
FDA 회수
2026-09-23
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532…
FDA 회수
2026-09-23
Revision of PIC/S GMP Guide (PE 009-18)
PIC/S
2026-09-22
Scope 3 Sustainability in the Pharmaceutical Industry: Reality or Aspiration?
ISPE
2026-09-21
FDA Inspection as GMP Evidence? Swissmedic Opens Up a New Option
ECA Academy
2026-09-21
FDA Publishes Draft Guidance on Potency Testing of Active Immunotherapy Products
ECA Academy
2026-09-21
FDA Warning Letter: Deficiencies in Stability Testing, Supplier Qualification, Validation and CGMP Oversight
ECA Academy
2026-09-21
FDA Warning Letter: serious GMP Deficiencies at a Chinese API Manufacturer
ECA Academy
2026-09-21
FDA criticises Visual Inspection
ECA Academy
2026-09-21
How is GMP-compliant Calibration of Equipment and Devices carried out in the pharmaceutical Industry?
ECA Academy
2026-09-21
IRIS Portal: EMA expands digital Procedure Management
ECA Academy
2026-09-21
New Version of PDA Technical Report No. 60 on Process Validation Published
ECA Academy
2026-09-21
New: Coordination of GMP Inspections for Centrally Authorised Products
ECA Academy
2026-09-21
USP Draft Chapter on Leachables in Oral Drug Products
ECA Academy
2026-09-21
Report on the International Active Pharmaceutical Ingredient Inspection Programme 2017 – 2024
EMA
2026-09-21
ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Step 5
EMA
2026-09-21
Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
미국 관보
2026-09-21
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
미국 관보
2026-09-21
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
미국 관보
2026-09-21
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs
미국 관보
2026-09-21
Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
미국 관보
2026-09-21
[HC] IMAAVY: Affected lots may contain glass particles
캐나다 보건부 회수
2026-09-21
Automated Cross-Grade Material Transfer – A Perspective – Part II
ISPE

2026-09-14 주

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