Titles
- Assessing user fees under the biosimilar user fee amendments of 20171
- BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment1
- Benefit-risk assessment for new drug and biological products: guidance for industry1
- Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice1
- Best practices for convening a GRAS panel: guidance for industry1
- Bioanalytical method validation1
- Breakthrough Devices Program: guidance for industry and Food and Drug Administration staff1
- CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality: guidance for industry1
- Cancer clinical trial eligibility criteria: available therapy in non-curative settings1
- Cannabis and cannabis-derived compounds: quality considerations for clinical research : guidance for industry1
- Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment1
- Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool1
- Chronic rhinosinusitis with nasal polyps: developing drugs for treatment : guidance for industry1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff1
- 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
- Code of ethics of the American Medical Association, adopted May 18473