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Titles
- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- Adjusting for covariates in randomized clinical trials for drugs and biological products: guidance for industry1
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff1
- Are consumers well informed about prescription drugs?: the impact of printed direct-to-consumer advertising1
- 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
- CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality: guidance for industry1
- CMS should bolster its oversight of manufacturer-submitted average sales price data to ensure accurate Part B drug payments1
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- COVID-19: developing drugs and biological products for treatment or prevention1
- Chronic rhinosinusitis with nasal polyps: developing drugs for treatment : guidance for industry1
- Clinical drug interaction studies with combined oral contraceptives: guidance for industry1
- Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act1
- 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
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Cost savings1
- Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry1
- 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