« Previous
Next »
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
- Implantable devices: regulatory framework and reform options1
- Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act1
- Imported seafood safety: FDA and USDA could strengthen efforts to prevent unsafe drug residues : report to the chairman, Committee on Appropriations, U.S. Senate1
- In vitro drug interaction studies: cytochrome P-450 enzyme- and transporter-mediated drug interactions1
- Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators1
- 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 COVID-19 convalescent plasma1
- 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