FDA Roundup: March 3, 2023

FDA News Release

• For Immediate Release: March 03, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA published the FDA Voices, “FDA and FTC Collaborate to Advance Competition in the Biologic Marketplace,” by Patrizia Cavazzoni, M.D., director of the Center for Drug Evaluation and Research. The FDA and the Federal Trade Commission have been working to help advance competition for biologics, including biosimilars and interchangeable biosimilars. Together, they have developed an educational resource for consumers about biosimilars and interchangeable biosimilars to help address common misperceptions. Unwarranted concerns may discourage patients and their health care providers from using or switching to a biosimilar, so it is important to know the facts.
• On Wednesday, the FDA issued a discussion paper on artificial intelligence in drug manufacturing to help proactively prepare for the implementation of AI in drug manufacturing and its enabling digital infrastructure. The agency is asking interested stakeholders to provide input on certain areas of consideration identified in the discussion paper. Public feedback will help inform the FDA’s evaluation of our existing regulatory framework in the context of AI’s in drug manufacturing to ensure production of quality drugs for U.S. patients.
• On Wednesday, the FDA published the FDA Voices, “Collaboration and Scientific Innovation Stimulated Advancement in the Generic Drug Program in 2022,” by Susan M. Rosencrance, Ph.D., acting director of the Office of Generic Drugs (OGD) within the agency’s Center for Drug Evaluation and Research. In 2022, FDA’s OGD had a very productive year with work on the reauthorization of Congressional legislation, hundreds of generic drug approvals, including complex generics, and on international collaborations. The article links to the OGD 2022 Annual Report, where these approvals and other actions are discussed.
• On Wednesday, the FDA issued a final guidance, “Q13 Continuous Manufacturing of Drug Substances and Drug Products.” This guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.  The FDA will continue taking necessary steps to facilitate the pharmaceutical industry’s implementation of CM and other emerging technologies that can improve product quality and help address many of the underlying causes of drug shortages and recalls. 
• On Wednesday, the FDA issued a Letter to Health Care Providers to alert facilities and providers about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set Advanced that contains the oxygenator, heat exchanger and integrated centrifugal pump. The FDA is issuing this letter to ensure facilities and providers are aware of the manufacturer’s recall notice. 
• The Letter to Health Care Providers includes important information about this issue, including: 
  • recommendations for health care facilities and providers; 
  • actions that the FDA is taking to address the issue; and 
  • instructions for reporting problems with any medical device. 
• On Wednesday, the FDA and the University of Texas Medical Branch opened pre-registration for the annual training course, Achieving Data Quality and Integrity in Maximum Containment Laboratories, to be held April 24-28, 2023. With virtual and in-person options, this popular course helps address challenges associated with ensuring data quality and integrity in regulated studies conducted in maximum containment (BSL-4) laboratories. The FDA welcomes participants from government, industry and academia who are working to further development of medical countermeasures for biological threat agents that must be studied in these labs. In-person attendees will tour BSL-3 and BSL-4 labs and participate in hands-on training in a mock BSL-3/4 environment. There is no cost to attend, however seating is limited. To attend the in-person course in Bethesda and Frederick, Maryland, interested applicants should pre-register by Friday, March 10, 2023.
• On Tuesday, the FDA approved Skyclarys (omaveloxolone) as the first treatment for Friedreich’s ataxia, a rare, inherited, degenerative disease that damages the nervous system, characterized by impaired coordination and walking. Friedreich’s ataxia causes progressive damage to the spinal cord, peripheral nerves and the brain, resulting in uncoordinated muscle movement, poor balance, difficulty walking, changes in speech and swallowing and a shortened lifespan. The condition can also cause heart disease. This disease tends to develop in children and teenagers and gradually worsens over time.
• The most common side effects of Skyclarys were an increase in alanine transaminase and an increase of aspartate aminotransferase, which can be signs of liver damage, headache, nausea, abdominal pain, fatigue, diarrhea and musculoskeletal pain. See full prescribing information for additional information on the safety and effectiveness of Skyclarys.
• COVID-19 testing updates: 
  • As of today, 444 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 299 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 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 45 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1270 revisions to EUA authorizations.