FDA

FDA

Government Administration

Silver Spring, MD 751,134 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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    FDA

    751,134 followers

    At today’s 21st U.S.–sub-Saharan Africa Trade and Economic Cooperation Forum (AGOA), FDA Associate Commissioner Mark Abdoo co-chaired a session highlighting the importance of accelerating the ratification of the African Medicines Agency (AMA) treaty. “Supporting the AMA’s success contributes to enhancing public health, promotes economic growth, and strengthens regional integration,” he said. Currently, of the 55 African Union member states located on the continent, 37 have signed and/or ratified the AMA treaty that would establish a specialized agency of the African Union to facilitate the harmonization of medical product regulation across Africa.   “A unified, effective regulatory framework under the African Medicines Agency would have significantly enhanced access of medical products in Africa during the COVID-19 pandemic,” said Abdoo, who recently met with African regulators, industry, and WHO representatives in Kenya and Rwanda to discuss the continent’s regulatory capacity needs. Kigali, Rwanda, has been chosen as the headquarters for the AMA, and so the FDA is preparing to open an office at the U.S. Embassy there to provide technical advice to the AMA, he said.   Abdoo co-chaired the health breakout session, one of the several specialty sessions at this year’s three-day AGOA Forum, named after the African Growth and Opportunity Act. The Act was enacted in 2000 to provide eligible sub-Saharan African countries with duty-free access to the U.S. market for over 1,800 products, in addition to the more than 5,000 products that are eligible for duty-free access under the Generalized System of Preferences program. The forum has been held nearly every year since the Act’s passage to provide an opportunity for participants to discuss how to promote resilient, sustainable, and inclusive economic growth and development through trade and investment ties between the United States and sub-Saharan Africa. To see Abdoo’s full remarks: https://lnkd.in/gZM8K764

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    FDA

    751,134 followers

    Justin Macy from the National Association of Boards of Pharmacy and ASOP presented interesting statistics today at the FDA Controlled Substances Summit on the growing trends in purchasing pharmaceuticals online. Did you know that 54% of Americans have purchased medications from an online pharmacy, while 40,000 of those websites have been found selling prescription medications online without a license and failing to comply with pharmacy practice standards?

    • Text graphic displaying statistics related to illegal online pharmacy sales.
    • Bad Meds movie poster-style graphic, "The Story of a Fake."
  • View organization page for FDA, graphic
    FDA

    751,134 followers

    Today, FDA announced the issuance of warning letters to 80 brick and mortar retailers in 15 different states for selling unauthorized e-cigarette products popular with youth, including Elf Bar and Lost Mary. Additionally, FDA also announced the filing of complaints for civil money penalties against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes. https://lnkd.in/dFRmb-h3

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    FDA

    751,134 followers

    The FDA collaborated with PHUSE/CDISC to execute a pilot from September 2023 thru April 2024 to test the feasibility of using CDISC Dataset-JSON as a transport format for study data submitted with regulatory applications. The pilot aimed to demonstrate that CDISC Dataset-JSON can serve as a transport file for study data without loss of data and no significant impact to business operations. The presentation will present the findings of the pilot and next steps as published in the PHUSE white paper. View the webinar here ➡ https://lnkd.in/drPp4YSg

    Dataset-JSON Pilot Report and Next Steps

    Dataset-JSON Pilot Report and Next Steps

    fda.gov

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