«

Sep 03 2020

New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS

 

 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Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders – Draft Guidance 31 August 2020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Evaluating Cancer Drugs in Patients with Central Nervous System Metastases: Draft Guidance for Industry – Draft Guidance 25 August 2020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Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for Industry – Draft Guidance 17 August 2020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