- Clinical decision support software: guidance for industry and Food and Drug Administration staff1
- Clinical drug interaction studies with combined oral contraceptives: guidance for industry1
- Clinical trial imaging endpoint process standards1
- 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 for required warning statements on small-packaged cigars1
- Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry1
- Complicated intra-abdominal infections: developing drugs for treatment1
- Complicated urinary tract infections: developing drugs for treatment1
- 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 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 design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders 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
- Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)1
- 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