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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
- 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
- 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
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1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
- Assessing user fees under the Prescription Drug User Fee Amendments of 20171
- Assessing user fees under the biosimilar user fee amendments of 20171
- BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment1
- Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion1
- Bacterial vaginosis: developing drugs for treatment1