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Titles
- Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry1
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Breakthrough Devices Program: 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
- 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
- Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act1
- Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry1
- Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff1
- Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry1
- Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act1
- Health document submission requirements for tobacco products: (revised)1
- Listing of ingredients in tobacco products: (revised)1
- Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff1
- Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications1
- Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff1
- Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)1
- Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy1
- Waivers, exceptions, and exemptions from the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act: guidance for industry1
- Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry1