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제약바이오 규제 전문 문헌 · 총 3,769건

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FDAPharmacology/Toxicology2026. 03. 18.

General Considerations for the Use of New Approach Methodologies in Drug Development

FDAInvestigation & Enforcement, Current Good Manufact2026. 03. 18.

Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry

FDAUser Fees, Electronic Submissions, Drug Competitio2026. 03. 17.

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs

FDAPremarket, Gastroenterology-Urology2026. 03. 13.

Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff

FDA의약품 허가2026. 03. 09.

New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry

FDA의약품 허가2026. 03. 09.

Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry

FDAinspection_enforcement2026. 03. 06.

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection

식약처(MFDS)규제업무2026. 03. 06.

바이오생약심사부 업무수행편람의 작성 및 운영

식약처(MFDS)바이오의약품2026. 03. 06.

생물의약품 한약(생약)제제 심사 검토서 작성 요령

식약처(MFDS)규제업무2026. 03. 06.

바이오생약심사부 민원인 안내서 운영

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