ICYMI: Dr. Cheryl Anne Boyce, Director of the FDA Office of Minority Health and Health Equity (FDA OMHHE), spoke with Dr. Casey Dorr for a National #NativeAmericanHeritageMonth webinar. They spoke about how to improve Native American representation among researchers. Watch the recording: https://lnkd.in/eHsDHaN3
About us
The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
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http://www.fda.gov/
External link for FDA
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- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
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Updates
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Today, FDA posted the FY 2025 Generic Drug User Fee Amendments Science and Research Priority Initiatives which include expanding the use of artificial intelligence, bioequivalence for complex ingredients & dosage forms, and other enhancements. FDA determined the priority initiatives in collaboration with industry and the public, including feedback received during the FY 2024 Generic Drug Science and Research Initiatives Public Workshop (https://lnkd.in/eFUNb3Cj). FDA publishes the science and research priorities as a part of the agency’s commitment to industry and other parties interested in generic drug development and to further the generic drug science and research program’s mission. Read below or learn more at: https://lnkd.in/e6Uzj_FW
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FDA reposted this
🔔 Coming January 28-29! Join the SBIA conference Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA FDA’s Knowledge-aided Assessment and Structured Application (KASA) initiative is a creative regulatory approach for modernizing quality assessment and enhancing submission format. KASA is designed to capture and manage knowledge during the lifecycle of a drug product; establish rules and algorithms to facilitate risk identification, mitigation, and communication; perform computer-aided analyses of applications for a comparison of regulatory standards and quality risk across the repository of approved drug products and facilities; and provide a structured assessment that minimizes text-based narratives and summarization of information provided in applications. ➡️ Register early! https://lnkd.in/eRjmSMfg
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On December 4th at 11:00 a.m. EST, FDA CBER is hosting a public listening meeting to understand what patients and care partners consider when deciding whether to enroll in gene therapy clinical trials for patients in the pre-symptomatic or early stages of rare diseases. Interested in hearing these perspectives? Learn more and register here: https://bit.ly/4h3DB0p
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🩺 If you're an instructor for a healthcare professional program, be sure to look at FDA's curriculum materials to help improve students' understanding of biosimilar and interchangeable biosimilar products and the regulatory approval pathway in the United States. https://bit.ly/3Yay3c5
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Read our article and watch our newest prescriber testimonial video on stigma and prescribing medications for opioid use disorder.
What practitioners Say About Prescribing with Confidence
FDA on LinkedIn
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⚕️ Students pursuing a health professional degree, check out the FDA's latest educational toolkit on biosimilar and interchangeable products. All materials are free to access: https://bit.ly/3Yay3c5
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FDA reposted this
📣 Coming January 22! SBIA | BsUFA III Regulatory Science Pilot Program: Progress Update webinar The agenda includes a recap of the activities of regulatory science pilot program from the last engagement that occurred on October 16, 2023. Additionally, the webinar will include a status update on the programs current research portfolio as it relates to the BsUFA III commitments as well as presentations and panel discussions by FDA staff. Lastly, FDA staff will present the next steps planned for the BsUFA III regulatory science program. 🗓️ Mark your calendars and register today! https://lnkd.in/euKDyYMj
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Learn about research that explores if adding a concise summary of risk information communicates drug safety information to busy healthcare providers, and supports their clinical decision-making for lactating patients in the latest Spotlight on CDER science: https://lnkd.in/gyqtKBhX
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FDA approved a drug to treat adults with cardiomyopathy of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems. To learn more and view the prescribing information, visit: https://lnkd.in/eUSd7EJN
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