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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
- Increases in reimbursement for brand-name drugs in Part D1
- Individuals' use of online medical records and technology for health needs1
- Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff1
- Interoperability among office-based physicians in 2015 and 20171
- 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