- Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry1
- Competitive generic therapies: guidance for industry1
- Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry1
- Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food, Drug, and Cosmetic Act: immediately in effect guidance for industry1
- Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act1
- Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff1
- Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies: guidance for industry, investigators, and institutional review boards1
- 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
- Content of premarket submissions for device software functions: guidance for industry and Food and Drug Administration staff1
- Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry1
- Cross labeling oncology drugs in combination regimens: guidance for industry1
- Cybersecurity in medical devices: quality system considerations and content of premarket submissions : guidance for industry and Food and Drug Administration staff1
- 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
- DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry1
- Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: guidance for industry1
- Development and licensure of vaccines to prevent COVID-19: guidance for industry1
- Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry1
- Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders1
- Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry1
- Drug-drug interaction assessment for therapeutic proteins: guidance for industry1