FDA Roundup: July 23, 2024

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

• On Monday, the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.

  “Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”

  The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.

• On Monday, the FDA published common questions received related to laboratory developed tests (LDTs). To ensure transparency, the FDA intends to respond to generally applicable questions, as appropriate, in a public manner, such as in webinars, guidances, FAQ page, and other resources over the course of the phaseout period for the general enforcement discretion to help assure the safety and effectiveness of in vitro diagnostic products offered as LDTs. The FDA intends to update the FAQ page periodically. For assistance with questions not answered on the FAQ page, please contact the FDA through the mailbox at ldtfinalrule@fda.hhs.gov.
• On Monday, the FDA announced an update to the Influenza Diagnostic Tests web page, indicating that LDTs for Highly Pathogenic Avian Influenza (HPAI) offered by clinical laboratories that are certified under Clinical Laboratory Improvement Amendments (CLIA) and qualified to perform high-complexity testing currently fall under the FDA’s general enforcement discretion approach for LDTs. The FDA generally does not expect clinical laboratories that are certified under CLIA and qualified to perform high-complexity testing to request marketing authorization from the FDA for their LDTs for HPAI prior to them offering those LDTs. The FDA would not issue Emergency Use Authorizations for such in vitro diagnostics given that there is no relevant section 564 declaration.
• On Thursday, July 18, the FDA announced an update about the ongoing evaluation of quality and performance issues related to plastic syringes made in China. Specifically, the FDA announced the issuance of an additional warning letter to Jiangsu Shenli Medical Production Co., Ltd. for quality system violations for syringe products. As a result, the company’s entry on import alert 89-04 was expanded to prevent their enteral syringes from entering the U.S. A warning letter was also issued to Jiangsu Caina Medical Co. Ltd. for quality system violations. The FDA recommendations have been updated to include that users should also immediately transition away from using enteral syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd., unless use of these syringes is absolutely necessary until the transition to enteral syringes manufactured by a different manufacturer can be completed.
• On Thursday, July 18, the FDA announced a public workshop titled Accreditation Scheme for Conformity Assessment (ASCA) and Use of Chemical Analysis to Support Biocompatibility of Medical Devices that will be held on Wednesday, November 6, 2024. The purpose of this public workshop is to discuss the possible expansion of the ASCA Program to include chemical analysis to support biocompatibility of medical devices. The workshop will be at the FDA’s White Oak campus in Silver Spring, Md., and webcast. Those attending by webcast will be in listen-only mode. The registration deadline is Wednesday, October 30, 2024. Please submit comments to Docket FDA-2024-N-3336 by December 6, 2024.
• On Thursday, July 18, the FDA published the FDA Voices “Catching Up with Califf: Men’s Health is Falling Behind – Some Thoughts About Why,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. In this part two of a series on men’s health, Dr. Califf further examines the potential underlying reasons for the decline in men’s health. 
• On Thursday, July 18, the FDA authorized the marketing of seven e-cigarette products in the United States through the premarket tobacco product application pathway. Following an extensive scientific review, the FDA issued marketing granted orders to R.J. Reynolds Vapor Company for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled, and non-refillable:
  • Vuse Alto Pod Golden Tobacco 5%
  • Vuse Alto Pod Rich Tobacco 5%
  • Vuse Alto Pod Golden Tobacco 2.4%
  • Vuse Alto Pod Rich Tobacco 2.4%
  • Vuse Alto Pod Golden Tobacco 1.8%
  • Vuse Alto Pod Rich Tobacco 1.8%

  While the FDA is authorizing the marketing of these tobacco products in the U.S., it does not mean these tobacco products are safe nor are they “FDA approved.”

• On Wednesday, July 17, the FDA published the FDA Voices: “FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients,” by Patrizia Cavazzoni, M.D., director of the Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research. The FDA plans to establish a Rare Disease Innovation Hub (the Hub). The Hub will work across rare diseases but will especially focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood.
• On Tuesday, July 16, the FDA published the FDA Voices: “From Awareness to Action: Tackling the Rising Burden of Common Chronic Diseases,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. In this FDA Voices, Dr. Califf expounds on the recent decline in life expectancy in the U.S. largely due, in part, to the cumulative impact of common chronic diseases. Chronic diseases of the heart, lungs, kidneys, liver, and metabolism (such as obesity and diabetes) account for the vast majority of deaths in this country.
• On Tuesday, July 16, the FDA issued a draft guidance for industry, “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease (IBD). Specifically, this guidance provides the agency’s recommendations about the necessary attributes of clinical studies for drugs being developed for the treatment of pediatric ulcerative colitis or pediatric Crohn’s disease, including study design, study population, efficacy considerations and safety assessments. This is the agency’s first guidance focused on clinical studies for drugs for the treatment of pediatric IBD. When finalized, this guidance will represent the FDA’s current thinking on this topic.  
• On Thursday, July 25, from 12-4 p.m. ET, the FDA will host a virtual public meeting to discuss the Home as a Health Care Hub initiative. During this meeting, the FDA will review the Home as a Health Care Initiative, seek input from the public, and start a dialogue about barriers and opportunities associated with making the home part of the health care system. Participants should register by July 25, at 11 a.m. ET. 

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