Today, we approved a medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. https://lnkd.in/eY4EK36Q
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.
- Website
-
http://www.fda.gov/
External link for FDA
- Industry
- Government Administration
- Company size
- 10,001+ employees
- Headquarters
- Silver Spring, MD
- Type
- Government Agency
- Specialties
- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
Locations
-
Primary
Get directions
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
-
NEW FDA RESOURCE: Check out frequently asked questions and answers about software functions that may be described as clinical decision support (CDS). Sponsors can use this information to help guide them in identifying whether their CDS software meets the FDA definition of a medical device. Find out more: https://lnkd.in/ewnyJU3W
-
-
CDER researchers are developing an approach that enables sharing and analyzing large volumes of cardiac electrophysiology in vitro data and streamlines the analysis and interpretation of these nonclinical data to support clinical cardiac safety decision making. Learn more in this Regulatory Science Impact Story: https://lnkd.in/ebqiN7DS
-
-
We've approved the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not feasible. https://lnkd.in/ec-QM6rm
-
-
FDA approved a treatment, used with diet, to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that prevents the body from breaking down fats (TG) in the bloodstream. Learn more at: https://lnkd.in/e7jQAqmG.
-
-
Today, we are announcing a final rule to update the definition of the nutrient content claim “healthy.” https://lnkd.in/e9MBAPRy This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels. The updated “healthy” claim marks an important step in fulfilling the FDA’s nutrition priorities, which are part of a whole-of-government approach to address this crisis.
-
-
FDA updated the list of off-patent, off-exclusivity drug products without an approved generic to include 20 new entries. This list is part of FDA’s efforts to improve transparency and identify brand products lacking competition. The 500+ drug products that make up these Rx and OTC lists are not protected by patents or exclusivities, nor do they have any approved generic applications. We update the lists every six months to support improved access to medicines for patients by encouraging the development and submission of ANDAs in markets with little competition. Learn more here: https://lnkd.in/dn_UmGp
-
-
FDA approved a treatment for steroid-refractory acute graft versus host disease in pediatric patients. Learn more and view the FDA-approved prescribing information at: https://lnkd.in/gCgdr6Tx
-
-
Now Available! FDA has published the “Office of Generic Drugs (OGD) Global Affairs Generic Drug Cluster: A Third Anniversary Reflection Paper,” which outlines how regulatory agencies from around the world share knowledge, address common challenges, and align, when appropriate, on best practices around the development of generic drugs. OGD established a multi-country forum in 2021 to help achieve a common understanding of each member agency’s generic drug regulatory requirements and to help increase scientific alignment that could encourage industry to develop more generic medicines. The reflection paper describes how agencies have addressed issues regarding bioequivalence approaches, in-vitro and in-vivo testing standards, and approval standards for complex parenteral drugs. 📖 Read the full reflection paper: https://lnkd.in/evCJUm78
-
-
📣Calling all Artificial Intelligence (AI) innovators! Pre-register today to join us in solving tough AI problems through the precisionFDA Generative AI (GenAI) Community Challenge: Democratizing and Demystifying AI. The latest precisionFDA Challenge, hosted by FDA’s Office of Digital Transformation, will launch on January 10, 2025. Participants will help push the boundaries of what is possible with GenAI to help shape the future of public health. Submit your innovative solutions by February 28, 2025. Spread the word by sharing this opportunity with others who may be interested in this crowdsourcing Challenge. 📅Pre-registration is encouraged: https://lnkd.in/gu92rV3s] 🔎Learn more about the latest precisionFDA Challenge: https://lnkd.in/gteCtXTK 🔎Learn more about precisionFDA: https://precision.fda.gov/ 🔎Read FDA’s IT Strategy to learn how the agency is leveraging emerging data and technology to safeguard and improve public health: https://lnkd.in/gMis_6RR
-