December 15, 2023: FDA Roundup including issuingdraft guidance intended to help animal drug sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug.
November 21, 2023: FDA Roundup including the Center for Veterinary Medicine publication of a Perspectives with CVM blog post, CVM Antimicrobial Stewardship in FY 2023 and Beyond, in recognition of 2023 World Antimicrobial Awareness Week (November 18-24).
FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus
On November 09, 2023, FDA approved Ixchiq, the first chikungunya vaccine.
Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.
FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection
On November 15, 2023, FDA ranted marketing authorization to LetsGetChecked for the Simple 2 Test. This is the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization.
Prior to this authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor’s office.
The Simple 2 Test is available over-the-counter (OTC) and is intended for use in adult patients ages 18 years and older. It is the first FDA-authorized test with at-home sample collection for any sexually-transmitted disease other than HIV.
On December 22, 2023, FDA issued a guidance for industry titled, “Rare Diseases: Considerations for the Development of Drugs and Biological Products" to clarify the FDA’s thinking on important considerations in rare disease drug development to ultimately assist rare disease drug and biologic product developers in conducting successful drug development programs.
On December 20, 2023, FDA issued the draft guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which describes updates to the 510(k) Third Party Review program and addresses how the FDA may rely on third parties to review EUA requests to enable the FDA to rapidly expand its resources during a future emergency.
On December 20, 2023, FDA issued the final guidance: Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization. This guidance replaces the guidance issued in February 2021 titled Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency and provides updated recommendations that reflect the evolving scientific knowledge and the current state of COVID-19.
On December 18, 2023, FDA issued a draft guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance is an update to the current final guidance to propose clarification about how the FDA evaluates real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in the FDA’s regulatory decision-making for medical devices and also proposes expanded recommendations to sponsors considering using real-world evidence to support regulatory submissions for medical devices.
On December 14, 2023, FDA issueddraft guidance intended to help animal drug sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug.
On November 22, 2023, FDA issued the final guidance “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention” that provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. (This supersedes the guidance of the same name initially issued on May 12, 2020, and reissued on February 22, 2021.)
March 01, 2024: FDA’s virtual Rare Disease Day. 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.
Information for industry and health care providers
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.
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/handsanitizerlistfor the latest, and learn more about safely using hand sanitizer.
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