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Titles
- 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
- 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
- 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
- Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff1
- 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
- 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
- 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
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- As funding for BPA research increased, NIEHS followed its peer review process while also exercising its discretion1
- Assessing user fees under the Prescription Drug User Fee Amendments of 20171
- Assessing user fees under the biosimilar user fee amendments of 20171