Titles
- Comparing outcomes for dual eligible beneficiaries in integrated care: final report1
- 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
- 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 building federal data capacity for patient-centered outcomes research related to intellectual and developmental disabilities1
- 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
- Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)1
- Control of nitrosamine impurities in human drugs1
- Conventional Foley catheters--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1