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Titles
- Administrative rulemaking2
- CMC postapproval manufacturing changes for specified biological products to be documented in annual reports2
- Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards2
- Disparities in health and health care: five key questions and answers2
- Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)2
- 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 plasma2
- Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff2
- Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry2
- Recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood components2
- Referencing approved drug products in ANDA submissions2
- Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff2
- Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff2
- Risk evaluation and mitigation strategies: modifications and revisions2
- Submission of plans for cigarette packages and cigarette advertisements (revised)2
- Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)2
- Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)2
- 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff1
- 340B Drug Discount Program: oversight of the Intersection with the Medicaid Drug Rebate Program needs improvement : report to Congressional requesters1
- 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations1