NYSDA Publications

FDA Issues Comprehensive Regulatory Update

Jul 23, 2024

The United States Food and Drug Administration (FDA) has issued its weekly comprehensive regulatory update, which can be read below.

The latest from FDA

UpdatesPublic health emergency response and other updates from FDA since our last MCMi email include:

More FDA press announcements


MCMi Program Update

Annual report on FDA's work to support medical countermeasure-related public health preparedness and response efforts

MCMi FY23 report cover

In case you missed it, FDA recently published the Medical Countermeasures Initiative (MCMi) Program Update report, which showcases FDA's work each year to prepare for all types of public health emergencies. Covering fiscal year 2023, the report includes updates on FDA's work agency-wide to support development of and access to medical countermeasures for a variety of public health threats. Download a printable PDF.

HPAI response updates 

Highly pathogenic avian influenza (H5N1 HPAI) in dairy cows  

Updates on Highly Pathogenic Avian Influenza (HPAI) in dairy cows
FDA and USDA announced results from a first-of-its-kind study using the process typically used by commercial milk processors. The intention of this study was to further confirm that pasteurization is effective at inactivating H5N1 HPAI virus in fluid milk and other dairy products made from pasteurized milk.

The study (PDF) – the only one to date designed to simulate commercial milk processing – found that the most commonly used pasteurization time and temperature requirements were effective at inactivating the H5N1 HPAI virus in milk. These results complement the FDA’s initial retail sampling study in which all 297 samples of dairy products collected at retail locations were found to be negative for viable H5N1 HPAI virus.
Collectively, these studies provide strong assurances that the commercial milk supply is safe. (June 28, 2024)


Recent updates from FDA and our federal partners:

Additional information from FDA and our federal partners:

Consumer information on milk safety from FDA:

 

Antimicrobial resistance update

FDA authorizes C. auris test

methicillin-resistant Staphylococcus aureus (image: NIAID)
FDA authorized marketing of DiaSorin Molecular LLC’s Simplexa C. auris Direct, a molecular-based assay intended to detect Candida auris (C. auris) DNA from a skin swab of the armpit or groin from patients suspected of C. auris colonization. The test is intended to help prevent and controlC. auris infections in health care settings.

The assay may allow health care professionals to evaluate patients for colonization with C. auris faster than traditional culture-based techniques when such testing is needed. Faster detection can help stop the spread of this organism, which is frequently resistant to multiple antifungal drugs and can cause serious infections in hospitalized patients. Test results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory information available to the clinician evaluating the patient. The test is not intended to diagnose or monitor treatment for C. auris infection.

This is the latest example of the FDA’s ongoing commitment to helping ensure the development and expansion of tests for emerging infectious pathogens. (July 15, 2024)

Emergency Use Authorization (EUA) updates

Emergency Use Authorization (EUA)

EUA revocation

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

EUA quick links

Events

More events: FDA Meetings, Conferences and Workshops

Information for industry and health care providers

Essential drug delivery outputs for devices intended to deliver drugs and biological products, with examples of people using combination products

 

FDA issues draft guidance to help streamline development of drug delivery devices

On June 28, 2024, FDA announced the draft guidance, Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. The guidance is intended to facilitate and streamline development of stand-alone devices, and combination products with device constituent parts, intended to deliver drugs and biological products, by improving the consistency of drug delivery performance information developed and included in applications.

In response to industry and trade group/stakeholder requests, this guidance provides additional clarity, transparency, consistency, and predictability in the type of information to ensure that a device’s drug-delivery function consistently performs as intended. It includes examples of potential EDDOs for several product types including prefilled syringes, injectors, nasal sprays, and inhalation devices.

FDA welcomes comments on this draft guidance. We encourage interested parties to submit comments by September 30, 2024, to ensure consideration before FDA begins work to finalize this guidance.

For more information see:

Addressing misinformation about medical devices and prescription drugs

FDA issued a draft guidance for industry, Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers, which, when finalized, will describe the agency’s current thinking on common questions companies may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This revised draft guidance would apply only to approved/cleared medical products, which include medical devices for human use (including biological products), prescription human drugs (including biological products), and prescription animal drugs. Learn more (July 8, 2024) 		Compass representing FDA guidance

Application user fees for combination products

FDA announced the revised final guidance Application User Fees for Combination Products. Combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate. This guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application.  When separate applications are submitted for the constituent parts of a combination product, the document explains how the Agency applies user fees.  It also includes revisions for consistency with current medical device and drug user fee programs and legislation. This guidance replaces the final guidance of the same title issued in 2005. (July 16, 2024)

COVID-19 convalescent plasma guidance

FDA issued Guidance for Industry: Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma. This guidance provides FDA’s recommendations to blood establishments for the submission of a Biologics License Application (BLA) for the manufacture of COVID-19 convalescent plasma for transfusion intended to treat patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. The guidance also provides FDA’s recommendations for Investigational New Drug applications (INDs) for investigational COVID-19 convalescent plasma for transfusion. (July 21, 2024)

Comment deadline extended

On May 28, 2024, FDA issued the Platform Technology Designation Program for Drug Development draft guidance. The comment period has been extended, and comments are now due August 28, 2024.

Expiration Date Extension

Expiration date extension

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:
  • June 28, 2024: When FDA first issued the EUA authorizing Pemgarda (pemivibart), it established a 24-month shelf-life. One lot of Pemgarda manufactured prior to the EUA issuance was labeled with an 18-month expiry. FDA has authorized extended expiration dates for this lot to reflect the 24-month product shelf-life (see Table 1 here). Pemgarda is currently authorized for emergency use for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents. The retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.
Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information about expiration date extensions of at-home COVID-19 tests.

In case you missed it

MCMi program update FY 2021
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Q&A with FDA podcast
In this podcast series, FDA’s Division of Drug Information answers some of the most commonly asked questions received by FDA. Previous episodes include conversations about drug shortages, expanded access, avoiding medication scams, and much more.

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Quick COVID-19 resources

Frequently Asked Questions
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.