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May 01 2020

New FDA Gudiances for April 2020 and Upcoming Advisory Committee Meetings

By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS

 

 Special Interest Guidances/Information Date Posted
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry – Final Guidance 30 April 2020
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for Industry – Final Guidance 29 April 2020
eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 27 April 2020
Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff – Final Guidance 24 April 2020
Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 23 April 2020
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 23 April 2020
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 22 April 2020
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 22 April 2020
Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 22 April 2020
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 21 April 2020
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry: Guidance for Industry – Final Guidance 20 April 2020
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency – Final Guidance 16 April 2020
Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 16 April 2020
CVM GFI #259 (VICH GL58) Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV – Final Guidance 14 April 2020
Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 14 April 2020
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products: Guidance for Industry – Final Guidance 13 April 2020
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 10 April 2020
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry: Guidance for Industry – Final Guidance 09 April 2020
Investigational COVID-19 Convalescent Plasma: Guidance for Industry – Final Guidance 08 April 2020
Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 06 April 2020
Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 06 April 2020
Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 06 April 2020
Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and FDA Staff – Final Guidance 05 April 2020
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 04 April 2020
CVM GFI #270 – Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency – Final Guidance 03 April 2020
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act – Final Guidance 03 April 2020
Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 03 April 2020
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 02 April 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 02 April 2020
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry – Final Guidance 02 April 2020
Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Guidance for Industry – Final Guidance 02 April 2020
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff – Final Guidance 02 April 2020
Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 01 April 2020

 

Upcoming Meetings (* = New)
  April 21, 2020: Pulmonary-Allergy Drugs Advisory Committee
  April 23-24, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee [POSTPONED]
  May 8, 2020: Cellular, Tissue and Gene Therapies Advisory Committee
  June 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee [POSTPONED]

Last updated: 01 May 2020