FDA

FDA

政府管理

Silver Spring，MD 775,003 位关注者

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关于我们

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.

网站
https://www.fda.gov/
所属行业
政府管理
规模
超过 10,001 人
总部
Silver Spring，MD
类型
政府机构
领域
Food、Drugs、Medical Devices、Vaccines Blood and Biologics、Animal and Veterinary、Cosmetics、Radiation-Emitting Products、Tobacco Products、Regulatory Research和Toxicological Regulatory Research

地点

  • 主要

    10903 New Hampshire Ave

    US，MD，Silver Spring，20993

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动态

  • 查看FDA的公司主页，图片
    FDA

    775,003 位关注者

    Today in New Delhi, India, FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak delivered the keynote speech at the official opening session of the 19th Annual International Conference of Drug Regulatory Authorities. Regulatory counterparts from about 119 countries were in attendance. At the FDA, “our long-term vision is a global marketplace which consistently offers high-quality medical products …regardless of where they are manufactured or used,” she said, in a speech that focused on the importance of risk mitigation, partnership building, and regulatory harmonization. “Inspecting our way to quality” isn’t feasible, Trzeciak said. “No regulatory authority can do everything on its own. Every member of the supply chain plays a critical role in its success.” Instead, what’s critical is encouraging a culture of quality and developing partnerships that better position the FDA and its counterparts to mitigate the numerous risks that could impact access to high quality medicines and vaccines.? Trzeciak concluded by operating strong support for the World Health Organization's new WHO-Listed Authority process, which sets transparent, quantitative, standards for identifying advanced performing regulatory authorities and promotes reliance. This means that regulatory authorities that lack the resources or expertise to perform a function may confidently rely on WLAs for decisions and to guide competency building, which in turn furthers international harmonization, facilitates product access, and enables supply chain integrity, she said. Typically held every two to three years, the ICDRA provides the regulatory authorities of WHO Member States with a forum to promote the exchange of information and collaborative approaches to issues of common concern. This year’s meeting is taking place October 14-18 with the theme of “Smart Regulation: Delivering Quality Assured Medical Products for All.” The conference is hosted by India’s Central Drugs Standard Control Organization and the Ministry of Health and Family Welfare in addition to the WHO.? https://lnkd.in/ejh73vJA

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  • 查看FDA的公司主页，图片
    FDA

    775,003 位关注者

    Don't miss this opportunity to network with experts and peers in the pharmaceutical industry at our upcoming workshop Nov. 6-7! Register now! https://lnkd.in/ed8y237A Discuss the latest nitrosamine research, recommendations, and best practices for ensuring drug safety, efficacy, and quality.

    • Conference banner reading "Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products." The event is scheduled for November 6-7, 2024, 8:30am-5:30pm. The banner includes text details, a QR code for more information, and FDA and Complex Generics logo in bottom corner.
  • 查看FDA的公司主页，图片
    FDA

    775,003 位关注者

    Today, FDA published the final guidance for industry,?Requests for Reconsideration at the Division Level Under GDUFA:?https://lnkd.in/ep8rrCH8 The guidance provides recommendations on the procedures for generic drug applicants that wish to pursue a request for reconsideration of an FDA review decision. FDA issued this guidance as part of our Drug Competition Action Plan, which seeks to expand?access to safe, high-quality, effective generic medicines:?https://lnkd.in/dM8f6ydU

  • 查看FDA的公司主页，图片
    FDA

    775,003 位关注者

    REMINDER: Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products is the Patient Engagement Advisory Committee- #PEAC2024 topic of discussion. The FDA will host this virtual meeting on Wednesday, October 30, 2024, 10 a.m. – 5:00 p.m. ET. During this meeting, the Patient Engagement Advisory Committee will discuss and make recommendations on patient-centered informed consent in clinical studies of FDA regulated medical products. Find out more. https://lnkd.in/eErk3Z-H

    • Promotional image for the FDA virtual event titled 'Patient-centered Informed Consent in Clinical Study of FDA-Regulated Medical Products' scheduled for October 30, 2024. The graphic features illustrations of diverse individuals in medical and discussion settings, enclosed within a circle, accompanied by healthcare symbols.

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