Patients are hearing about #biosimilars - and asking questions. As more biosimilars are approved in the US, the FDA wants healthcare providers to understand what these products are and how they can be prescribed to help patients. To support this, we have developed educational materials to help healthcare providers gain a better understanding of these important types of medication. Find resources here: https://bit.ly/4cXGq0c #PatientCare
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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/
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Aktualisierungen
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📢 Join us Sept 24 from 1-2 PM ET for a free CE webinar on FDA's Bad Ad Program. Learn about prescription drug promotion and its regulation along with information on how healthcare professionals can report potentially false or misleading prescription drug promotion to the FDA. Register here ➡️ https://lnkd.in/gSRzHznA
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🔔Coming October 9: ICH M12 Drug-Drug Interaction Studies Final Guidance If your work relates to drug interactions, drug metabolism, pharmacokinetics, or clinical pharmacology, attend this SBIA webinar! The discussion will include content related to the full scope of the ICH M12 Drug Interaction Studies guidance. Register early! https://lnkd.in/e6ygc4HH
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⚠️ The deadline to speak at our 9/20 patient listening meeting is this Friday. Share your perspective on safety considerations of approved gene therapies for rare genetic diseases and long term studies after receiving gene therapies. Request to speak here: https://bit.ly/3XUEQrP
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FDA revised the Emergency Use Authorization (EUA) for Pemgarda (pemivibart) to limit its use in the event that SARS-CoV-2 variants with substantially reduced susceptibility to Pemgarda reaches a certain threshold: https://lnkd.in/gYKuNmYa For more information, read the Frequently Asked Questions: https://lnkd.in/gc5Ysfnn
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Join the FDA and the Reagan-Udall Foundation for the FDA for a hybrid public meeting on September 6, 2024 to discuss efforts to accelerate treatment development for Post-Traumatic Stress Disorder (PTSD), including psychedelic drug development. Register today: https://lnkd.in/gUKinWt6
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🎧Interested in real-world evidence, real-world data, & how FDA continues to promote reliable evidence to support the safety & effectiveness of drug products? Listen to the latest “Q&A with FDA” podcast with Dr. Hilary Marston, FDA’s Chief Medical Officer: https://lnkd.in/gRPen-HS
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Join us on September 10, 2024, from 1-2 PM ET as we host a webinar for those interested in learning more about the Remanufacturing of Medical Devices Final Guidance. During the webinar, the FDA’s staff will discuss and answer questions related to the final guidance. Find out more: https://lnkd.in/eaptJak8
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Mammography update: to help facilities better understand and comply with the latest regulations related to mammography services and the Mammography Quality Standards Act (MQSA), we issued a Small Entity Compliance Guide (SECG). The SECG contains important information about: · The scope of the 2023 MQSA Rule — A final rule that was issued in March 2023, · How facilities should communicate with patients and provide mammogram results, · Requirements for reporting breast density, and · Recommendations of how facilities should comply with MQSA. This compliance guide is intended to replace the Policy Guidance Help System, which will be discontinued when the 2023 MQSA Rule amendments become effective on September 10, 2024. Learn more: https://lnkd.in/enRnkWa3