Registration open for annual training course on achieving data quality and integrity in clinical trials involving high-consequence pathogens

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

• August 15, 2023: FDA Roundup including publication of “Catching Up with Califf: FDA’s Dietary Supplements Program Remains a Critical Priority.
• August 11, 2023: FDA Roundup including clearance of the V-PRO maX 2 Low Temperature Sterilization System for the sterilization of 3D printed devices in health care facilities.
• August 08, 2023: FDA Roundup including issuance of draft guidance, “QTc Information in Human Prescription Drug and Biological Product Labeling.
• August 04, 2023: FDA Roundup including publication of FDA Voices: ”Emerging From the Pandemic: CDRH In-Person Meeting Status and Premarket Workload.
• August 01, 2023: FDA Roundup including an FDA and Drug Enforcement Administration update on the ongoing actions being taken to resolve the shortages of prescription stimulant medications.

• On July 31, 2023, FDA cleared the BD Respiratory Viral Panel (BD RVP) for BD MAX System intended for the simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) nucleic acid.  

EUA revocations

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

• August 03, 2023: SPERA COVID-19 Ag Test (Xtrava Health)

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• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked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

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. 

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

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 450 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.