September 2, 2022 - FDA Roundup: September 2, 2022

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: “Using A Whole-Of-Governments Approach to Combating Illicit Health Products,” by Cathy Hermsen, Assistant Commissioner for Criminal Investigations and Ritu Nalubola, Director of the FDA’s Europe Office. Criminal networks are increasingly sophisticated and capable of exploiting regulatory, legal and other gaps to ship and/or transship illicit and potentially dangerous health products to the U.S., putting patients at risk. Combatting this threat requires a whole-of-governments approach - the collaboration of multiple countries employing multiple authorities and multiple agencies. The U.S. and the UK have demonstrated the success of this approach with their ongoing Operation Lascar program. Now the FDA wants to encourage wide-scale adoption of this approach. To this end, the FDA and the Organization of Economic Co-Operation and Development have co-hosted a series of meetings with government officials from nearly 20 countries in preparation for a workshop in Paris on September 15-16 with representatives from the public and private sectors and multinational organizations. 
• On Thursday, the FDA continued warning consumers to “Beware of Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation”. This new, short Consumer Update amplifies a safety communication FDA's Center for Devices and Radiological Health recently issued. Both pieces warn consumers about the potential risk of injury associated with the use of certain brands of UV wands. These wands should not be used because they may expose you or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes or both after a few seconds of use.
• On Thursday, the FDA announced a virtual meeting of its Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee on Thursday, October 20, to discuss, make recommendations and vote on clinical information related to the De Novo request for the AvertD Test, a prescription diagnostic genetic test to identify if a patient may be at increased risk for developing Opioid Use Disorder, sponsored by SOLVD Health, Inc.
• On Wednesday, September 7, the FDA will hold a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS). The committee will reconvene the panel from the March 30, 2022, PCNS meeting to further discuss the new drug application 216660, for sodium phenylbutyrate/taurursodiol (AMX0035) submitted by Amylyx Pharmaceuticals, Inc. AMX0035 is proposed to be indicated for the treatment of amyotrophic lateral sclerosis (ALS). The meeting will take place from 12-6:30pm ET. For more information and the meeting materials, visit the meeting information webpage.
• COVID-19 testing updates:
  • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 301 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
  • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1106 revisions to EUA authorizations.

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