FDA News Release
FDA Roundup: March 4, 2022
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA published the FDA Voices: “CDER Continues to Make Rare Diseases a Priority with Drug Approvals and Programming to Speed Therapeutic Development,” bylined by Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). In the first two months of 2022, CDER approved four new drugs for people with rare diseases in the areas of oncology and hematology. Last year, 26 of CDER’s 50 novel drug approvals, more than half, were for orphan diseases.
- On March 1, NASA, the National Institutes of Health (NIH), the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), and the FDA announced the award of eight contracts in a multi-agency collaboration to extend longevity of complex in vitro (human) models, such as 3D tissue chips and microphysiological systems, to at least six months. Currently, such chips are viable for about one month, limiting researchers’ ability to track longer-term effects of treatments on tissues using these systems. Results from longer studies could be used to better understand disease models, supporting development of and clinical trial design for a variety of medical countermeasures.
- COVID-19 testing updates:
- As of today, 419 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests and 44 antigen tests. There are 70 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 859 revisions to EUA authorizations.
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.
- FDA Office of Media Affairs