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FDA Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
Guidance for Industry DRAFT
This guidance is intended to assist applicants and other responsible parties in fulfilling the FDA's existing postmarketing safety reporting requirements for human marketed drug and biological products at 21 CFR 310.305, 314.80, 314.98, 600.80, and 600.81 2.

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