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Titles
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- Acne vulgaris: establishing effectiveness of drugs intended for treatment1
- Allergic rhinitis: developing drug products for treatment1
- Anthrax: developing drugs for prophylaxis of inhalational anthrax1
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Assessing user fees under the Prescription Drug User Fee Amendments of 20171
- Assessing user fees under the biosimilar user fee amendments of 20171
- BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment1
- Bioanalytical method validation1
- Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Clinical trial imaging endpoint process standards1
- 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
- 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
- Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances1
- Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff1
- Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment1