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Jun 08 2020

New FDA Gudiances for May 2020 and Upcoming Advisory Committee Meetings

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

 

 Special Interest Guidances/Information Date Posted
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) – Final Guidance 28 May 2020
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry – Final Guidance 28 May 2020
Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 27 May 2020
Orange Book Questions and Answers Guidance for Industry: Draft Guidance for Industry – Draft Guidance 27 May 2020
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers – Final Guidance 26 May 2020
Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents: Draft Guidance for Industry – Draft Guidance 26 May 2020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 26 May 2020
Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 May 2020
Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry – Final Guidance 22 May 2020
Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines: Guidance for Industry – Final Guidance 22 May 2020
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 21 May 2020
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma: Guidance for Industry – Final Guidance 19 May 2020
Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic: Guidance for Industry – Final Guidance 12 May 2020
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic – Final Guidance 11 May 2020
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry – Final Guidance 11 May 2020
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products : Guidance for Industry and Investigators – Final Guidance 11 May 2020
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff – Final Guidance 11 May 2020
CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency – Final Guidance 07 May 2020
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 06 May 2020
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry – Final Guidance 05 May 2020
Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 04 May 2020
Investigational COVID-19 Convalescent Plasma: Guidance for Industry – Final Guidance 01 May 2020

 

Upcoming Meetings (* = New)
  June 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee [POSTPONED]
* June 17-18, 2020: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (pedsODAC) [UPDATED AGENDA AND PUBLIC PARTICIPATION INFORMATION]

Last updated: 05 June 2020