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 Reminder: CARES Act Drug Shortage Mitigation Efforts reporting deadlines

  • Reports for calendar year 2020 should be submitted no later than 15 February 2022
  • Reports for calendar year 2021 should be submitted no later than 16 May 2022
For application holders filing eCTD submissions via ESG, please note that beginning 1 March 2022, all submissions using eCTD Module 1 U.S. Regional DTD must be version 3.3. As of March 1st, any submission using eCTD Module 1 U.S. Regional DTD Version 2.01 will be outdated and the system will reject the submission.

As noted in the FDA Roundup: January 4, 2022, the agency has implemented temporary changes to its inspectional activities due to the COVID-19 pandemic, and the spread of the omicron variant. The FDA had announced that through 19 January 2022 it intended to temporarily postpone certain inspectional activities, although mission critical inspections will continue. This inspection ‘pause’ has been extended through 4 February 2022 with the goal of restarting activities as soon as safely possible. The agency is continuing to provide oversight by leveraging a variety of tools, including remote assessments and import operations surveillance.

FDA plans to proceed with previously identified foreign surveillance inspections that have received country clearance provided they are within the CDC’s Level 1 or Level 2 COVID-19 travel recommendation; otherwise, the inspection will be rescheduled. The agency is hoping to return to their regular process for foreign surveillance inspections in April. State inspections under FDA contract and cooperative agreements have the discretion to make inspection decisions based on their local information.

The FDA’s Recognized Consensus Standards database has been updated with new standards, and new versions of recognized standards. The updated database is known as “List 57”. Although the Federal Register notice will not be published until later in 2022, manufacturers are welcome to cite the new and revised standards in their device submissions. Included are format changes to the listing of US Pharmocopeia-National Formulary (USP-NF) standards.

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products White Paper: IWGACP Scientific Opinions On Testing Methods fir Asbestos in Cosmetic Products Containing Talc

Guidance Documents of Interest

Pathology Peer Review in Nonclinical Toxicology Studies: Q and A

This guidance provides information to sponsors and nonclinical laboratory staff regarding the management and conduct of pathology peer review performed during good laboratory practice-compliant toxicology studies. When conducted, pathology peer review should be well-documented. This question-and-answer document is intended to clarify FDA’s recommendations concerning the management, conduct, and documentation of pathology peer review.

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act

This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during or in advance of a public health emergency.

FDA is issuing this guidance to assist stakeholders in the Agency’s implementation of section 506J of the FD&C Act outside of the COVID-19 public health emergency, and will serve as the baseline for information about notifications under section 506J of the FD&C Act during or in advance of any public health emergency

Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

FDA is issuing this guidance to provide FDA’s enforcement policies regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency.

All Guidance Documents can be searched on the FDA’s website.

Federal Register Notices

FR Vol 87, No. 7 Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability


For those that missed the FDA OTC Monograph Reform: OTC Sunscreen Drugs webinar, a recording is now available for review.

FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials – Considerations and Lessons Learned from the Changing Landscape

Date: March 7 – 9, 2022

Time: 7:30 AM – 12:00 PM ET

FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada will provide attendees with insight into key topics, compliance trends and the opportunity to hear first-hand from regulators about lessons learned from the changing clinical trial landscape.

Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance

Date: February 10, 2022

Time: 1:00 PM – 2:30 PM ET

Technological advances provide opportunities to facilitate efficient clinical investigations. The FDA intends to provide the clarity needed to encourage the exploration of these technological advances.

Posted in Drug and Device Corner, Drugs, Medical Devices.