Titles
- Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff1
- Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions1
- Clinical investigations for prostate tissue ablation devices: guidance for industry and Food and Drug Administration staff1
- Clinical trial imaging endpoint process standards1
- Community-acquired bacterial pneumonia: developing drugs for treatment1
- Competitive generic therapies1
- 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
- Compliance policy for required warning statements on small-packaged cigars1
- Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)1
- 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
- Connecting kids to health coverage: evaluating the Child Health and Disability Prevention Gateway program1
- 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 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 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