FDA

Today, the FDA is taking action to restrict the sale of unapproved ingestible fluoride prescription products for young children. We’ve sent notices to 4 companies outlining the agency’s intention to take action against those that market unapproved fluoride-containing ingestible drug products. https://lnkd.in/eUaszBw6 FDA concluded that such products should not be used in children under age three or by older children who are not at high risk of tooth decay. For the same reason fluoride may work to kill bacteria on teeth, it may also alter the gut microbiome, which may have broader health implications. Better alternatives exist to protect children's teeth.

The FDA posted materials for the virtual Digital Health Advisory Committee meeting scheduled Nov. 6. The committee will discuss and make recommendations on the topic of generative AI-enabled digital mental health medical devices. Access the meeting agenda, roster, executive summary, discussion questions, and webcast link on our website. Also, learn how to submit written public comments. https://lnkd.in/ewCGN3a5

Today, the FDA announced significant actions to accelerate biosimilar development and lower drug costs for Americans. Our new draft guidance proposes major changes to simplify biosimilar studies and reduce unnecessary clinical testing. More affordable treatment options are coming. https://lnkd.in/evA6yJBW

Today, the FDA issued the first-ever Emergency Use Authorization for an animal drug. FDA concluded that, based on the scientific evidence available, it is reasonable to believe that the drug may be effective in treating New World screwworm infestations in dogs and puppies, and the known and potential benefits of the product outweigh its known and potential risks. https://lnkd.in/es4hTudS

Today, FDA approved revumenib for adult and pediatric patients 1 year and older with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.  https://lnkd.in/epxA9sGU   The prescribing information includes warnings and precautions for differentiation syndrome, QTc interval prolongation, and embryo-fetal toxicity.    Learn more in the FDA-approved prescribing information at: https://lnkd.in/emUfeBq 

The FDA's internal drug application filing checklists are now public! These checklists will help drug sponsors submit complete applications the first time. Fewer procedural delays = faster access to potentially life-saving treatments for patients who need them. https://lnkd.in/gbeYbVAh

Registration is now open to attend the FDA Rare Disease Innovation Hub’s November 20th Rare Disease Innovation, Science, and Exploration (RISE) Workshop on individualized therapies.   This public workshop will examine the emerging science and regulatory environment for individualized medicine programs. It will provide opportunities for members of the rare disease community, including researchers, sponsors, patients, patient advocates, and regulators, to share their experiences with individualized medicine approaches.   Register here: https://lnkd.in/euFBKM9U

FDA released the guidance snapshot for the final guidance Conducting Clinical Trials with Decentralized Elements. https://lnkd.in/e--DE9Uv https://lnkd.in/exDQdykh FDA’s Guidance Snapshot Pilot Program aims to increase the general public’s awareness of and engagement with FDA guidance documents—and support the efficient application of the recommendations. The snapshot highlights key points in the guidance document and is not a substitute for the guidance document. 

FDA issued guidance today permitting animal drug sponsors to use dual labeling for FDA-approved animal drugs if FDA conditionally approves the same drug for New World screwworm-related indications. This action helps streamline labeling changes on animal drug products needed to respond to the NWS threat at the U.S./Mexico border. https://lnkd.in/eBA58bPe

FDA is aware of news reports of devastating contamination in children’s cough and cold medicine in India. The agency has confirmed these products have not been shipped to the U.S. https://lnkd.in/eNUVpRmX