FDA Roundup: January 20, 2023

SILVER SPRING, Md., Jan. 20, 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 an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to bolster supply of pediatric ibuprofen amid record high demand. The guidance clarifies FDA’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.

• On Thursday, the FDA announced the availability of a draft guidance titled, “Mpox: Development of Drugs and Biological Products”. The draft guidance provides the FDA’s current thinking regarding nonclinical, virology, and clinical considerations for mpox (monkeypox) drug development programs.

  The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of mpox. Comments and suggestions regarding this draft guidance should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

• On Thursday, the FDA published the final rule: Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products. The FDA believes the amendments and repeals will help ensure that the requirements for radiation emitting electronic products and medical devices will continue to protect the public health and safety against harmful exposure to radiation emitting products and medical devices while reducing regulatory burdens.
• COVID-19 testing updates:
  • As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 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, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 44 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1213 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.

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SOURCE U.S. Food and Drug Administration