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Titles
- 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
- 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations1
- A few states fell short in timely investigation of the most serious nursing home complaints: 2011-20151
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff1
- Access and use of electronic health information by individuals with cancer: 2017-20181
- Acne vulgaris: establishing effectiveness of drugs intended for treatment1
- Adaptive designs for clinical trials of drugs and biologics1
- Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff1
- Administrative rulemaking2
- Adolescent and young adult substance use: federal grants for prevention, treatment, and recovery services and for research : report to Congressional committees1
- Advancement of emerging technology applications for pharmaceutical innovation and modernization1
- Alaska State Medicaid Fraud Control Unit: 2016 onsite review1
- Allergic rhinitis: developing drug products for treatment1
- Alternative procedures for blood and blood components during the COVID-19 public health emergency1
- Amyotrophic lateral sclerosis: developing drugs for treatment1
- Anthrax: developing drugs for prophylaxis of inhalational anthrax1
- Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases1
- Antibiotic resistance: more information needed to oversee use of medically important drugs in food animals : report to Congressional requesters1