Expedited safety reporting requirements for human drug and biological products; correction--FDA. Final rule; correction.
The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of October 7, 1997 (62 FR 52237), to include some conforming amendments that were inadvertently omitted. The final rule amended the expedited safety reporting regulations for human drug and biological products. This action is being taken to ensure the accuracy and consistency of the regulations.
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration