Recent regulatory news

Recent news from regulators and industry bodies that the weekly brief did not carry, in date order.

Read this week's brief Weekly brief archive

Week of 2026-11-09

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That DIBENZYLINE (Phenoxybenzamine Hydrochloride) Oral Capsule, 10 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Federal Register
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
Federal Register
2026-11-13
[HC] SECARIS NASAL GEL: Affected lot may contain foreign matter
Health Canada recall
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
Federal Register
2026-11-12
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Qualified Importer Program
Federal Register
2026-11-12
Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry; Availability
Federal Register
2026-11-12
Patient-Level Data for Drugs and Biological Products Submissions Containing Real-World Data and Real-World Evidence; Request for Information
Federal Register
2026-11-12
Hematology and Pathology Devices; Reclassification of Immunohistochemistry Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
Federal Register
2026-11-12
Class 4 Medicines Defect Notification: Star Pharmaceuticals Ltd, Enalapril maleate/ Hydrochlorothiazide 20 mg/12.5 mg Tablets, EL(26)A/48
UK 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
Federal Register
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
Federal Register
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…
Federal Register
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)
Health Canada recall
2026-11-09
Expanding the Pharmaceutical Quality Framework: Part 1 - Leveraging AI-Derived Insights Across CMC, Process Validation, and Quality Systems
ISPE

Week of 2026-11-02

2026-11-06
Food Additive Petitions; Change of Address
Federal Register
2026-11-06
Quality Unites: Building Community Beyond Compliance: Why Quality Needs Communities More Than Ever
ISPE
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
Class 3 Medicines Recall: Aspire Pharma Limited, Tropicamide 1% Eye Drops, solution in single dose containers 20 x 0.5ml , EL(26)A/47
UK 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
UK 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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
2026-11-04
Wechem Hand Guard8/1000mL Bag, Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013
FDA recall
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 recall
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 recall
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 recall
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 recall
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
Federal Register
2026-11-03
Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability
Federal Register
2026-11-03
[HC] ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL and Potential Bag Leaks
Health Canada recall
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
Federal Register
2026-11-02
[HC] Cyclophosphamide for Injection USP: Presence of particulate matter
Health Canada recall

Week of 2026-10-26

Week of 2026-10-19

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
Federal Register
2026-10-23
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products
Federal Register
2026-10-23
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program
Federal Register
2026-10-23
Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO
Federal Register
2026-10-23
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability
Federal Register
2026-10-23
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
Federal Register
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
Federal Register
2026-10-21
[HC] Femyso: Affected lot may contain two green Mifepristone cartons or two pink Misoprostol cartons instead of one of each.
Health Canada recall
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 recall
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 recall
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 recall
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 recall
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 recall
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
Federal Register
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
Health Canada recall

Week of 2026-10-12

Week of 2026-10-05

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
Federal Register
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
Federal Register
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
Federal Register
2026-10-09
Challenges and Solutions in Lot-Level Food Traceability; Public Meeting
Federal Register
2026-10-09
Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Federal Register
2026-10-09
Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC
Federal Register
2026-10-09
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction
Federal Register
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
Federal Register
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
Federal Register
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…
Federal Register
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
Federal Register
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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
Federal Register
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…
Federal Register
2026-10-06
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction
Federal Register
2026-10-06
[HC] Carvedilol 25 mg Tablets: Out-of-specification (Impurity)
Health Canada recall
2026-10-06
[HC] PMS-Carvedilol 25 mg Tablets: Out-of-specification (Impurity)
Health Canada recall
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)
Health Canada recall
2026-10-05
[HC] PDP-DIPHENHYDRAMINE 25 MG CAPSULE: Out-of-specification (Impurity)
Health Canada recall
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
UK MHRA

Week of 2026-09-28

2026-10-02
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October
EMA
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
Federal Register
2026-10-01
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal
Federal Register
2026-10-01
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program
Federal Register
2026-10-01
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Federal Register
2026-10-01
Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees
Federal Register
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
Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
UK 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
Federal Register
2026-09-30
Annex 1 and Global Harmonization on Aseptic Filling: Insights from the 2026 ISPE Aseptic Conference Regulatory Panel
ISPE
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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)…
Federal Register
2026-09-29
Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Federal Register
2026-09-29
FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters
Federal Register
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.
Health Canada recall

Week of 2026-09-21

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…
Federal Register
2026-09-25
Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Federal Register
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…
Federal Register
2026-09-25
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
Federal Register
2026-09-25
[HC] Limited number of Sarclisa single use vials may have been frozen during shipment
Health Canada recall
2026-09-25
[HC] Sanofi-Aventis Canada Inc. recalling certain insulin pens and cartridges
Health Canada recall
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
Federal Register
2026-09-24
[HC] Apo-Semaglutide Injection : Incorrect dose display
Health Canada recall
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
UK 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 recall
2026-09-23
Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
FDA recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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 recall
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
Federal Register
2026-09-21
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
Federal Register
2026-09-21
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
Federal Register
2026-09-21
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs
Federal Register
2026-09-21
Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
Federal Register
2026-09-21
[HC] IMAAVY: Affected lots may contain glass particles
Health Canada recall
2026-09-21
Automated Cross-Grade Material Transfer – A Perspective – Part II
ISPE

Week of 2026-09-14

Past 60-day window · 402 items · as of 2026-11-13. Titles are the originals published by each agency or body and link to the source page. These were collected separately from the brief's selection, so judge their relevance to your work yourself.

Not shown on this English page: 45 items whose original titles are in Korean. See the Korean page for these.