FDA

When will the facilities first registered with FDA on or after the declaration of the COVID-19 PHE for the sole purpose of producing hand sanitizer products during the COVID-19 PHE need to cease production of hand sanitizer products and deregister from FDA's eDRLS to avoid FY 2025 facility fees? A. Cease production of hand sanitizer products and update registration and listing accordingly, before 12:00 a.m. EST on December 31, 2024 B. No need to do anything C. 45 days after the publication of the federal register notice D. None of the above 💡 Test your knowledge in anticipation of our upcoming OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration by responding to the question below. The answer will be posted once the poll closes. Register to attend the webinar ➡ https://lnkd.in/dafKebhU

Portable bed rails can be helpful for adults, aged 65 and older, at home, as well as in assisted living facilities and residential care facilities. However, some people are at a higher risk for entrapment, falls, or injuries from using bed rails. To prevent injuries, regularly assess that bed rails remain appropriately matched to the equipment and to the person’s individual needs, considering all relevant risk factors. Check out the FDA’s safety recommendations for health care providers using portable bed rails: https://lnkd.in/eUVu6nPA #OlderAmericansMonth

#CBEROTP has published a new draft guidance with recommendations regarding safety testing of human allogeneic cells expanded for use in cell-based medical products. Sponsors can review the guidance and submit comments to the docket through July 29, 2024. https://bit.ly/3xVD3HP

The FDA’s Center for Devices and Radiological Health and the Office of Digital Transformation’s precisionFDA are launching Phase 1 of the Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge on May 28. The DEFoGD Challenge seeks artificial intelligence (AI) models to identify and predict freezing of gait (FoG) events related to Parkinson’s disease. Medical device developers, tech innovators, software developers, and academic researchers are invited to participate. The top performing AI models from Phase 1 will advance and be evaluated against validated FoG data in Phase 2. Register to participate in the DEFoGD Challenge today: https://lnkd.in/eTXanqhm

This Clinical Trials Day we celebrate the breakthroughs in science and technology that bring new opportunities to advance innovation in medicine, which help provide novel treatment options for patients and make clinical trials more accessible.  Learn more in this FDA Voices article ➡ https://lnkd.in/euVebyjV The recently established Center for Clinical Trial Innovation (C3TI) will enable and amplify innovative approaches to clinical trials that are designed to improve the efficiency of drug development.  Learn more about C3TI ➡ https://lnkd.in/gwmKUxsj 

Do you need to know more about inspections of Bioavailability/Bioequivalence (BA/BE) and nonclinical Good Laboratory Practice (GLP) studies submitted to FDA? Join us for the OSIS Workshop on June 13, 2024! Register here ➡ https://lnkd.in/dNguqmBz

FDA approves two interchangeable biosimilars to treat macular degeneration and other eye conditions:  https://lnkd.in/etnqmDVe

Today, the FDA Oncology Center of Excellence announced The OCE Equity Program. The new program expands Project Equity, continuing the Oncology Center’s work to improve access to clinical trials of oncology medical products for populations that have been historically underrepresented in clinical research. The OCE named Nicole Gormley, MD, and Tamy Kim, PharmD, as directors of The OCE Equity Program. Dr. Gormley is the Associate Director for Equity Advancement in the OCE, and director of the Division of Hematologic Malignancies 2 in the FDA Office of Oncologic Diseases. Dr. Kim is the OCE Director for Regulatory Affairs and Policy. https://lnkd.in/dwttWdtg #OCEEquityProgram

📢 Are you interested in learning directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics? Then join us for the 13th annual Regulatory Education for Industry (REdI) on May 29th-30th, 2024! Register here ➡ https://lnkd.in/e6yYMTUZ