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Apr 06 2020

New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS

FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.

 

 Special Interest Guidances/Information Date Posted
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 30 Mar 2020
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 29 Mar 2020
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry: Guidance for Industry – Final Guidance 27 Mar 2020
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 27 Mar 2020
Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency : Guidance for Industry – Final Guidance 26 Mar 2020
Compliance Policy Guide Section 110.800 Post Detention Sampling Guidance for Industry – Final Guidance 24 Mar 2020
CVM GFI #269 – Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak – Final Guidance 24 Mar 2020
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry – Final Guidance 24 Mar 2020
CVM GFI #108 Registering with CVM’s Electronic Submission System – Final Guidance 23 Mar 2020
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals – Final Guidance 22 Mar 2020
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 22 Mar 2020
Enforcement Policy for Non-Invasive Remote 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 20 Mar 2020
Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)  – Final Guidance 19 Mar 2020
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic – Final Guidance 19 Mar 2020
Submission of Plans for Cigarette Packages and Cigarette Advertisements – Final Guidance 19 Mar 2020
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic : Guidance for Industry, Investigators, and Institutional Review Boards – Final Guidance 18 Mar 2020
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry – Draft Guidance 17 Mar 2020
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide: Guidance for Industry – Final Guidance 17 Mar 2020
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 17 Mar 2020
Competitive Generic Therapies – Final Guidance 16 Mar 2020
Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry: Guidance for Industry – Final Guidance 16 Mar 2020
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff – Final Guidance 16 Mar 2020
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency – Final Guidance 14 Mar 2020
Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry – Final Guidance 12 Mar 2020
510(k) Third Party Review Program: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations – Final Guidance 12 Mar 2020
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry: Draft Guidance for Industry – Draft Guidance 11 Mar 2020
Q3D(R1) ELEMENTAL IMPURITIES – Final Guidance 10 Mar 2020
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry – Draft Guidance 10 Mar 2020
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 09 Mar 2020
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry – Draft Guidance 06 Mar 2020
Inclusion of Older Adults in Cancer Clinical Trials: Draft Guidance for Industry – Draft Guidance 06 Mar 2020
Safety Testing of Drug Metabolites – Final Guidance 05 Mar 2020
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers : Guidance for Industry – Final Guidance 04 Mar 2020
Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 04 Mar 2020
Bone Anchors – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 03 Mar 2020

 

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

Last updated: 06 April 2020