New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings
Special Interest Guidances/Information | Date Posted |
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders - Draft Guidance | 31 August 2020 |
CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs - Final Guidance | 27 August 2020 |
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry - Final Guidance | 27 August 2020 |
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components: Guidance for Industry - Final Guidance | 26 August 2020 |
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases: Draft Guidance for Industry - Draft Guidance | 25 August 2020 |
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers: Guidance for Industry - Final Guidance | 19 August 2020 |
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) : Guidance for Industry - Final Guidance | 18 August 2020 |
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for Industry - Draft Guidance | 17 August 2020 |
Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff - Final Guidance | 14 August 2020 |
Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff - Final Guidance | 14 August 2020 |
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff - Final Guidance | 14 August 2020 |
Male Breast Cancer: Developing Drugs for Treatment: Guidance for Industry - Final Guidance | 12 August 2020 |
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic ActMarketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act - Final Guidance | 10 August 2020 |
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Draft Guidance for Industry - Draft Guidance | 07 August 2020 |
Bioresearch monitoring technical conformance guide - Final Guidance | 05 August 2020 |
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry - Final Guidance | 05 August 2020 |
Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants - Final Guidance | 04 August 2020 |
CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products - Final Guidance | 31 Jul 2020 |
CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents - Final Guidance | 31 Jul 2020 |
Upcoming Meetings (* = New) | ||
* | Oct 22, 2020: Patient Engagement Advisory Committee Meeting | |
* | Oct 22, 2020: Vaccines and Related Biological Products Advisory Committee | |
* | Oct 07, 2020: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting | |
* | Oct 02, 2020: Vaccines and Related Biological Products Advisory Committee | |
* | Sep 15, 2020: Pediatric Advisory Committee Meeting | |
* | Sep 10-11, 2020: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting | |
Sep 08-09, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting |
Last updated: 01 September 2020