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Titles
- IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards1
- Imported seafood safety: FDA and USDA could strengthen efforts to prevent unsafe drug residues : report to the chairman, Committee on Appropriations, U.S. Senate1
- Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff1
- Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops2
- Investigational enzyme replacement therapy products: nonclinical assessment1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- Investigational new drugs: FDA has taken steps to improve the expanded access program but should further clarify how adverse events data are used : report to Congressional addressees1
- Investigational new drugs: FDA's expanded access program : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives1