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2026년 6월 4주차 규제뉴스

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for TAZVERIK (tazemetostat) tablet, 200 milligrams (mg), held by Epizyme, Inc., an Ipsen Company (Epizyme), 1 Main St., Cambridge, MA 02142.

The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II (special controls).

The Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device into class II (special controls).

The Food and Drug Administration (FDA) is classifying the endoscopic traction device into class II (special controls).

The Food and Drug Administration (FDA) is announcing the renewal of the Science Board to the Food and Drug Administration by the Commissioner of Food and Drugs (the Commissioner).

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 mg, and 54 mg, held by SpecGx LLC…

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of two Emergency Use Authorizations (EUA) (Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products.

The Food and Drug Administration (FDA) is classifying the ingestible gastrointestinal blood detection capsule into class II (special controls).

The Food and Drug Administration (FDA) is classifying the radiological machine learning-based quantitative imaging software with predetermined change control plan into class II (special controls).

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Andrew Jonathan Morgan for a period of 5 years from importing or offering for import any drug into the United…

①○ 의약품 제조업자는 의약품을 제조하면서 제조관리기준서, 제품표준서 등에 따라 정확히 제조하여야 하고, 작성된 기준서 및 지시서를 준수하여야 하나, ‘쎄파렉신캡슐(은교산)’, ‘소폐탕엑스과립(소청룡탕)’에 대하여 다음과 같이 기준서를 준수하지 않은 사실이 있음 - 제조관리기준서 ｢원료 칭량 관리｣(문서번호 PMN032, 승인일자 2025.

②10.

Product quality