FDA

FDA

Government Administration

Silver Spring, MD 747,395 followers

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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/
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

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Updates

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    FDA

    747,395 followers

    On May 6, 2024, we issued a final rule amending the FDA's regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to LDTs. On August 22, 2024, we will host a webinar for laboratory manufacturers and other interested stakeholders to discuss how to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files beginning May 6, 2025 (Stage 1 of the phaseout policy). All questions must be received by June 28, 2024, to be considered for the discussion. Questions will be not be taken during the live webinar. Learn more: https://lnkd.in/e5Q9vwFW

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    FDA

    747,395 followers

    Do you have patients that suffer from a chronic disease? Clinical trials play an important role in developing treatments for chronic diseases and are becoming more accessible and inclusive through innovations such as decentralized features and pragmatic designs. This #ChronicDiseaseDay, learn about the FDA's CDER Center for Clinical Trial Innovation (C3TI), a central hub that supports innovative approaches to clinical trials to improve the efficiency of drug development for chronic diseases and other conditions. Learn more: https://lnkd.in/gwmKUxsj

    • An adult patient is discussing with two healthcare professionals in a medical office. The patient is seated and gesturing during the conversation, while one healthcare professional is taking notes and the other is listening attentively. The room is well-lit with a window showing a view of trees. FDA logo in bottom right corner.
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    FDA

    747,395 followers

    We are alerting health care providers and facilities to stop using Medtronic NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes. Medtronic issued a recall for removal of all of these medical devices from inventory due to issues with tube blockage. Learn more: https://lnkd.in/e_E3ZETk

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  • View organization page for FDA, graphic
    FDA

    747,395 followers

    📣There's still time to register! Join FDA and Clinical Trials Transformation Initiative (CTTI) August 6, 2024 (10:00 AM- 5:30 PM EDT) for a free hybrid public workshop on artificial intelligence (AI) in drug and biological product development. AI holds great potential to transform how drugs are developed, manufactured, and utilized. As with any innovation, AI use in drug development creates new and unique challenges that require both careful management and a risk-based regulatory framework that is built on sound regulatory science approaches. This public workshop will explore guiding principles that are being applied by innovators and regulators to promote the responsible use of AI in the development of safe and effective drugs. Register today ➡️ https://lnkd.in/eP99VH_2

    • Graphic shows the silhouette of a speaker on stage, facing an audience also depicted as silhouettes, against a dark blue background. Text reads "Public Workshop, Aug. 6, 2024." FDA logo on bottom right corner.
  • View organization page for FDA, graphic
    FDA

    747,395 followers

    Today, FDA issued a draft guidance for industry, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which, when finalized, will describe FDA’s current thinking on common questions companies may have when voluntarily addressing misinformation related to their approved/cleared medical products: https://lnkd.in/e4gzBYT7   This revises the previous draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” issued in June 2014.  

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