FDA

Test your knowledge from today's Online Controlled Substances Summit: https://lnkd.in/gCXhQtrM

Are you a #raredisease patient or care partner? Interested in sharing your perspectives on safety considerations for approved #genetherapy treatments and long-term studies after gene therapy? Request to participate at our virtual listening meeting by 8/30: https://bit.ly/3XUEQrP

FDA published CDER’s Office of New Drugs’ (OND) second annual Research Outcomes Report: https://lnkd.in/g4FCg-TW. The purpose of this report is to summarize outcomes from OND-funded regulatory science research projects for fiscal years 2022-2023 This report is a celebration of OND’s contributions to the field of regulatory science research, which helps the agency make informed, evidence-based regulatory decisions. The projects featured focused on addressing targeted questions that will have an impact on new drug approval decisions and provide ample room for the expansion of this research with broad goals that could further increase the impact of the work. Visit OND's Research Program website for more information on how to get involved: https://lnkd.in/gt5uWn47

The #Paris2024 Summer Olympics are here! Did you know the FDA fights to keep our athletes safe? Selective androgen receptor modulators, commonly called SARMs, are chemical substances that mimic the effects of testosterone and anabolic steroids and are not FDA approved. SARMS are prohibited at all times for all competitive athletes. 🥇 Case reports of drug-induced liver injury (DILI) linked to SARMs raise serious concerns for the safety of recreational SARM users. A recent publication by Fahad Mostafa and minjun chen looked at machine learning to predict drug-induced liver injury and its validation on failed drug candidates in development. Check out the article below and read more about SARMs here: https://lnkd.in/g4A4ex7j

FDA recently added resources for the 2023 guidance, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” to its Guidance Snapshot Pilot Program: 📘 Guidance Snapshot: https://lnkd.in/gA2pneCY 🔊 Guidance Recap Podcast: https://lnkd.in/g-HKmnAz To access the snapshot guidance resources for this and other guidances in the pilot, visit: https://lnkd.in/eYmKdcK

At today’s 21st U.S.–sub-Saharan Africa Trade and Economic Cooperation Forum (AGOA), FDA Associate Commissioner Mark Abdoo co-chaired a session highlighting the importance of accelerating the ratification of the African Medicines Agency (AMA) treaty. “Supporting the AMA’s success contributes to enhancing public health, promotes economic growth, and strengthens regional integration,” he said. Currently, of the 55 African Union member states located on the continent, 37 have signed and/or ratified the AMA treaty that would establish a specialized agency of the African Union to facilitate the harmonization of medical product regulation across Africa.   “A unified, effective regulatory framework under the African Medicines Agency would have significantly enhanced access of medical products in Africa during the COVID-19 pandemic,” said Abdoo, who recently met with African regulators, industry, and WHO representatives in Kenya and Rwanda to discuss the continent’s regulatory capacity needs. Kigali, Rwanda, has been chosen as the headquarters for the AMA, and so the FDA is preparing to open an office at the U.S. Embassy there to provide technical advice to the AMA, he said.   Abdoo co-chaired the health breakout session, one of the several specialty sessions at this year’s three-day AGOA Forum, named after the African Growth and Opportunity Act. The Act was enacted in 2000 to provide eligible sub-Saharan African countries with duty-free access to the U.S. market for over 1,800 products, in addition to the more than 5,000 products that are eligible for duty-free access under the Generalized System of Preferences program. The forum has been held nearly every year since the Act’s passage to provide an opportunity for participants to discuss how to promote resilient, sustainable, and inclusive economic growth and development through trade and investment ties between the United States and sub-Saharan Africa. To see Abdoo’s full remarks: https://lnkd.in/gZM8K764

Today’s Controlled Substances Summit provided perspectives from FDA leadership and experts on the illegal online availability of controlled substances. Listen to Dr. Marta Sokolowska, Deputy Center Director for Substance Use & Behavioral Health, FDA, share closing remarks. Healthcare providers can help treat patients with opioid use disorder. Learn more: https://lnkd.in/d-W9FV-F #PrescribewithConfidence

Justin Macy from the National Association of Boards of Pharmacy and ASOP presented interesting statistics today at the FDA Controlled Substances Summit on the growing trends in purchasing pharmaceuticals online. Did you know that 54% of Americans have purchased medications from an online pharmacy, while 40,000 of those websites have been found selling prescription medications online without a license and failing to comply with pharmacy practice standards?

Check out the latest blog post from CDRH’s Digital Health Center of Excellence on the potential lifecycle management (LCM) holds for addressing the unique challenges of AI in health care. LCM considerations can help AI meet real-world needs while managing inherent risks across the software lifecycle. https://lnkd.in/dNMensDy

Today, FDA announced the issuance of warning letters to 80 brick and mortar retailers in 15 different states for selling unauthorized e-cigarette products popular with youth, including Elf Bar and Lost Mary. Additionally, FDA also announced the filing of complaints for civil money penalties against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes. https://lnkd.in/dFRmb-h3