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Titles
- FDA oversight3
- 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
- Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry2
- Risk evaluation and mitigation strategies: modifications and revisions2
- 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
- 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations1
- A sense of déjà vu: the debate surrounding state biosimilar substitution laws1
- 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
- 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
- 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