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Titles
- Administrative rulemaking2
- 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
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Assessment and synthesis of selected Medicaid eligibility, enrollment, and renewal processes and systems in six states1
- Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- 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
- Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act1
- Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry1
- Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act1
- Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act1
- Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace1
- Delivery reform1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Disparities in health and health care: five key questions and answers1
- Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders1
- Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)1
- FDA deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)1
- Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act1