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Titles
- Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry2
- Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)2
- 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations1
- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- Alternative procedures for blood and blood components during the COVID-19 public health emergency1
- 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
- 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
- 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
- Cancer clinical trial eligibility criteria: brain metastases1
- Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs1
- Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections1
- Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies1
- Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1