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Titles
- Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations1
- Benefit-risk assessment for new drug and biological products: guidance for industry1
- Bioavailability studies submitted in NDAs or INDs: general considerations1
- Chronic hepatitis B virus infection: developing drugs for treatment1
- 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
- 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
- Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry1
- Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns1
- Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry1
- Drug products, including biological products, that contain nanomaterials1
- Electronic submission of IND safety reports: technical conformance guide1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry1
- Orange Book: questions and answers1
- Population pharmacokinetics1
- Pre-Launch Activities Importation Requests (PLAIR)1
- Principles of premarket pathways for combination products: guidance for industry and FDA Staff1
- Providing regulatory submissions in electronic and non-electronic format: promotional labeling and advertising materials for human prescription drugs1