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Titles
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- Acne vulgaris: establishing effectiveness of drugs intended for treatment1
- Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff1
- Advancement of emerging technology applications for pharmaceutical innovation and modernization1
- Allergic rhinitis: developing drug products for treatment1
- Anthrax: developing drugs for prophylaxis of inhalational anthrax1
- Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases1
- 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
- Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice1
- Bioanalytical method validation1
- 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
- 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 trial imaging endpoint process standards1
- Compliance policy for required warning statements on small-packaged cigars1