« Previous
Next »
Titles
- 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff1
- 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations1
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff1
- Acne vulgaris: establishing effectiveness of drugs intended for treatment1
- Adaptive designs for clinical trials of drugs and biologics1
- 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
- Alternative procedures for blood and blood components during the COVID-19 public health emergency1
- Amyotrophic lateral sclerosis: developing drugs 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
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment1
- Assessing user fees under the Biosimilar User Fee Amendments of 20171
- Assessing user fees under the Prescription Drug User Fee Amendments of 20171
- Assessing user fees under the biosimilar user fee amendments of 20171