Learn how FDA develops the rules that determine how tobacco products must be made, marketed, sold, and distributed in the U.S. by watching the new video, “FDA Tobacco Rulemaking 101,” here ?? https://lnkd.in/d8-DTV9T
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
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https://www.fda.gov/
FDA的外部链接
- 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
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主要
获取路线
10903 New Hampshire Ave
US，MD，Silver Spring，20993
FDA员工
动态
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Comment period extended. Per trade association request, the comment period for Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food is open until January 21, 2025. Docket number FDA-2024-N-3609. https://lnkd.in/eKd3hVnS
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Learn about the latest FDA-recognized consensus standards, tips for FDA device submissions, and more in our latest Standards Newsletter. https://lnkd.in/er-HeQkS
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Today, the Food and Drug Administration approved updated drug labeling for fludarabine phosphate under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the third drug to receive a labeling update under Project Renewal. Announcement: https://lnkd.in/eB3FSMwG Learn more about OCE's Project Renewal: https://lnkd.in/dE_Q6Bf
Project Renewal
fda.gov
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In support of Diabetes Awareness Month, learn more about ??insulin #biosimilars and how they can provide a safe and effective treatment option for managing #diabetes: https://bit.ly/3BMSZy6
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Today, we issued the final guidance, “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.” This guidance supersedes the previous "510(k) Third Party Review Program" guidance. This final guidance clarifies how we will use third party review organizations to review 510(k) submissions and may use them to review EUA requests during public health emergencies. Learn more:
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FDA has published a batch of product-specific guidances (PSGs), including new PSGs for medications that treat diseases and conditions such as pulmonary hypertension, schizophrenia, atopic dermatitis, certain cancers, and others: https://lnkd.in/dBpZN4P When finalized, PSGs reflect FDA’s current thinking for developing generic drug products and generating evidence to support FDA approval of these products.
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In the latest From Our Perspective, read about the OTC Monograph drug user fee program (OMUFA) and how OTC monograph reform has helped increase efficiency, timeliness, and predictability of OTC monograph drug regulation, and streamlined safety updates: https://lnkd.in/eVKDG3Qa FDA will be holding a public meeting on the recommendations for the OMUFA Reauthorization on November 20. To learn more about registration and how to submit a comment, visit the link: https://lnkd.in/ecyYmJTJ
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This National #NativeAmericanHeritageMonth, watch Dr. Myra Parker as she talks about how her work with Tribal communities supports equity initiatives as part of the FDA Office of Minority Health and Health Equity's (FDA OMHHE) #REACHingCommunities video series: https://lnkd.in/e_Wj6fdn
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The Center for Devices and Radiological Health qualified a new patient-reported outcome instrument through the Medical Device Development Tools (MDDT) program. The WOUND-Q instrument assesses individual aspects of wound characteristics and impact on health-related quality of life for individuals with nonhealing chronic wounds (lasting three months or longer) in any area of the body. Find out more about the new tool. https://lnkd.in/ez73KUmN
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