September 23, 2022 - FDA Roundup: September 23, 2022

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: “FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death,” by Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health, Center for Drug Evaluation and Research. The FDA is building on actions to help expand the availability and access to this life-saving medication, an effort that it is hoped will be embraced by harm reduction programs and manufacturers.  
• On Thursday, the FDA issued the immediately-in-effect guidance, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency, which is intended to clarify the scope of the public health emergency (PHE) exclusion and exemption under the DSCSA as they apply to the distribution of FDA-approved naloxone hydrochloride (“naloxone”) to harm reduction programs during the opioid PHE. The FDA is issuing this guidance to help address some of the obstacles to naloxone access identified during community engagements. Further, the guidance supports the FDA Overdose Prevention Framework’s priority to encourage harm reduction by seeking to expand availability and access to naloxone.
• On Thursday, the FDA granted accelerated approval to Retevmo (selpercatinib) from Eli Lilly and Company for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. The most common adverse reactions (≥25%) in patients participating in clinical trials were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. The recommended selpercatinib dose based on body weight is (1) Less than 50 kg: 120 mg orally twice daily, (2) 50 kg or greater: 160 mg orally twice daily.
• Selpercatinib was also granted regular approval for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an FDA-approved test. The FDA approved the Oncomine Dx Target (ODxT) Test (Thermo Fisher Scientific) as a companion diagnostic for selpercatinib. Selpercatinib was previously granted accelerated approval for the NSCLC indication on May 8, 2020, based on initial overall response rate and duration of response in 144 patients enrolled in the LIBRETTO-001 trial (NCT03157128), a multicenter, open-label, multi-cohort trial. The conversion to regular approval was based on data from an additional 172 patients and 18 months of additional follow-up to assess durability of response.
• On Wednesday, the FDA issued the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions, which describes resources to support electronic submission of premarket notifications [510(k)s] to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research.
• On Wednesday, the FDA updated its Public Health Alert on Mother’s Touch Formula to inform parents and caregivers that Mother’s Touch has initiated a voluntary recall because their product did not conform to the FDA’s infant formula standards. While Mother’s Touch is advising consumers in their notice that parents and caregivers who have unused containers of Mother’s Touch Baby Formula should return them to the store where they were purchased, the FDA continues to recommend that consumers who have purchased this product discontinue use and throw them away.
• On Tuesday, the FDA published an interview with John Skerritt, the head of Australia’s Therapeutic Goods Administration, reflecting on Australia’s robust strategy for regional and global medical product engagement. The interview was timed to coincide with his visit to the FDA headquarters in Maryland for a series of meetings with FDA leadership. 
• 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 79 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 1120 revisions to EUA authorizations.
     

Related Information

###

---