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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
- 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
- In vitro drug interaction studies: cytochrome P-450 enzyme- and transporter-mediated drug interactions1
- Increases in reimbursement for brand-name drugs in Part D1
- Individuals' access and use of patient portals and smartphone health apps: 20201
- Individuals' use of online medical records and technology for health needs1
- 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
- Integrating Health and Human Services programs and reaching eligible individuals under the Affordable Care Act: final report1
- Integrating OB/GYN and SUD care: policy challenges and opportunities1
- Integrating SUD and OB/GYN care: policy challenges and opportunities : final report1
- 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 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