FDA Issues Weekly Comprehensive Regulatory Activities Update

Feb 10, 2024

The United States Food and Drug Administration (FDA) has issued its weekly comprehensive update on its regulatory activities. You can read the FDA weekly comprehensive regulatory activities update below.

The latest from FDA

Updates Public health emergency response and other updates from FDA since our last MCMi e-mail include:

January 31, 2024: CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk In Vitro Diagnostics (IVDs) - Reclassification may support the potential for more manufacturers to develop these tests, which could increase competition and provide patients with increased access to these tests.
January 29, 2024: FDA revises letter of authorization for the Emergency Use Authorization for Paxlovid (also see EUA section below)
January 26, 2024: FDA issued an expanded safety alert to warn consumers about nine additional products that contain toxic yellow oleander.
January 26, 2024: New Consumer Update and video: 10 Facts about What FDA Does and Does Not Approve
January 23, 2024: FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience
January 18, 2024: FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
January 17, 2024: FDA’s Center for Devices and Radiological Health (CDRH) issued its 2023 Annual Report
January 17, 2024: FDA announces shelf-life extension for naloxone nasal spray

More FDA press announcements

Register today: 2024 training course

Achieving Data Quality and Integrity in Maximum Containment Laboratories

April 15-19, 2024
Galveston, Texas or virtual

Join FDA and the University of Texas Medical Branch for a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in maximum containment (BSL-4) facilities. FDA welcomes participants from government, industry, and academia who are working to further development of medical countermeasures for biological threat agents that must be studied in these labs.

Attendance is free, but space is limited. Attendees must pre-register.

Learn more and pre-register

Regulatory science funding

Each year, FDA issues a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation, including for medical countermeasures. For FY 2024 consideration, submissions are due by 11:59 p.m. ET on February 20, 2024.

BAA quick links:

BAA (SAM.gov)
FY24 FDA Broad Agency Announcement Question and Answer Session (January 2024, recording and materials)
Learn more about the FDA BAA

Emergency Use Authorization (EUA) updates

FDA revises Paxlovid EUA letter of authorization

In December 2021, FDA authorized Paxlovid for emergency use for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. In May 2023, FDA approved Pfizer’s new drug application (NDA) for Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

On January 29, 2024, FDA announced a revision to the Paxlovid EUA, stating that Paxlovid manufactured and labeled in accordance with the EUA (EUA-labeled Paxlovid) currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. Both providers and patients should visit Pfizer’s website for information on lots of EUA-labeled Paxlovid that are the subject of a shelf-life extension. Lots of EUA-labeled Paxlovid not listed on Pfizer’s website may only be used through the labeled expiration date, or through March 8, 2024, whichever is earlier.

EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8, 2024, regardless of the labeled or extended expiration date. However, the Paxlovid EUA will continue to authorize emergency use of Paxlovid manufactured and labeled in accordance with the NDA (NDA-labeled Paxlovid) for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

EUA revocations

FDA revoked the following EUA for the reasons noted in the revocation letter (PDFs):

1/17/2024: TangenDx SARS-CoV-2 Molecular Test (Tangen Biosciences, Inc.)
1/16/2024: Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit (Bio-Rad Laboratories, Inc.)
1/16/2024: TaqPath COVID-19 Pooling Kit (Thermo Fisher Scientific, Inc.)

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.

EUA quick links

Emergency Use Authorization - about EUAs, and links to current EUAs
EUAs for Drugs and Non-Vaccine Biological Products (CDER)
EUAs for Medical Devices (CDRH)
COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
Historical Information about Device EUAs

Events

March 1, 2024: FDA Rare Disease Day 2024 (virtual) - Dedicated to patients and health care professionals. Panels will discuss efforts to address the unique challenges with developing treatments for rare diseases, as well as the FDA’s efforts to promote new medical products for patients with rare diseases. Free continuing education (CE) credit will be available for eligible health care professionals. Learn more and register.
March 5, 2024: Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice (Silver Spring, MD and virtual) - To discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs. To attend in-person, register by February 27, 2024.
March 5, 2024: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2024 to 2025 influenza season.
March 19-20, 2024: Enhancing Adoption of Innovative Clinical Trial Approaches (Washington, DC and virtual) - To discuss efforts to advance innovation of clinical trial design and conduct. Please register to attend in-person or virtually.
April 15-19, 2024: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Galveston, TX or virtual) - To discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in BSL-4 facilities. Pre-register to attend in person by March 20, 2024, or by March 29, 2024, to attend virtually.

More events: FDA Meetings, Conferences and Workshops

Information for industry and health care providers

Guidance and updates for industry

February 5, 2024: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act - Final guidance, to assist registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution
February 1, 2024: Conducting Remote Regulatory Assessments (RRAs) Questions and Answers - Draft guidance which, once finalized, will describe how the FDA intends to use RRAs for FDA-regulated products.

January 31, 2024: FDA issued the Quality Management System Regulation (QMSR) Final Rule to ensure medical devices on the market are safe, effective, and of good quality. The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.
January 29, 2024: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products - Draft guidance, to provide the FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and clinical studies for FDA-regulated medical products. Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to the FDA. Submit comments by April 29, 2024.

Expiration date extension

Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. Recent updates:

Paxlovid (January 29, 2024)
Naloxone (January 17, 2024)

In case you missed it

Quick COVID-19 resources

Check expiration date extensions for your COVID-19 tests
Get the latest on COVID-19 vaccines
Know your treatment options for COVID-19
Order free at-home COVID-19 tests

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 600 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.

NYSDA Publications