Titles
- 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- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1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
- BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment1
- Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion1
- Bacterial vaginosis: developing drugs for treatment1
- Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff1
- Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice1
- Bioanalytical method validation1
- Biocompatibility testing of medical devices: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff1
- Biological product deviation reporting for blood and plasma establishments1
- Blood glucose monitoring test systems for prescription point-of-care use: guidance for industry and Food and Drug Administration staff1
- Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff1
- 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