FDA Roundup: April 4, 2023

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Apr 04, 2023, 14:55 ET

SILVER SPRING, Md., April 4, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA issued draft Guidance for Industry #278, Human User Safety in New and Abbreviated New Animal Drug Applications, to clarify the current approaches and the FDA's recommendations for Human User Safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval.

On Monday, the FDA published a Spotlight on CDER Science examining pharmacodynamic (PD) biomarkers in biosimilar product development. The Spotlight summarizes some research that the FDA and outside investigators have been conducting in this area.

On Friday, the FDA provided an update from our ongoing postmarket evaluation of Essure by posting information on medical device reports received by the FDA related to Essure through 2022. The FDA remains committed to collecting and providing updates on the long-term safety information about Essure. Although Essure, a permanently implanted birth control device for women, has not been available for implantation in the U.S. since December 2019, the FDA continues to monitor the product's safety through postmarket surveillance study data and other activities.

COVID-19 testing updates:

As of today, 446 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 61 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and five for molecular OTC at-home tests.
The FDA has authorized 46 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1339 revisions to EUA authorizations.

Additional Resources:

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration