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Titles
- 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
- Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff1
- Adaptive designs for clinical trials of drugs and biologics1
- Administrative rulemaking1
- Amyotrophic lateral sclerosis: developing drugs 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
- Care provider facilities described challenges addressing mental health needs of children in HHS custody1
- Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff1
- Child-resistant packaging statements in drug product labeling1
- Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act1
- Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff1
- Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff1
- Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry1
- Compliance policy for limited modifications to certain marketed tobacco products1
- Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff1
- Considerations for the development of dried plasma products intended for transfusion1
- Considerations for the inclusion of adolescent patients in adult oncology clinical trials1
- Considerations in demonstrating interchangeability with a reference product1