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.
FDA的外部链接
10903 New Hampshire Ave
US，MD，Silver Spring，20993
FDA转发了
This week, I announced Operation Stork Speed to expand options for safe, reliable, and nutritious infant formula for American Families. The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them. Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.
FDA launches a new resource page for generic drug applicants! The webpage has on-demand trainings, presentations, and more to help improve the quality of ANDA submissions and potentially decrease the number of assessment cycles. Check out the new webpage: https://lnkd.in/eDm3yc-T
FDA approves the first treatment for adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. C3G is a rare disease that causes inflammation and damage to the kidney glomeruli, which are responsible for filtering blood and producing urine. Learn more:?https://lnkd.in/eN8siE9s
To increase transparency, today, FDA unveiled the Chemical Contaminants Transparency Tool, an online searchable database providing a consolidated list of contaminant levels that are used to evaluate potential health risks of contaminants in human foods. Prior to development of the consolidated list, some levels could be found only in specific guidance documents. The CCT Tool provides contaminant levels in one location for ease of searching. https://lnkd.in/eKN99rG8
Today, FDA announced the over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) facility fee rates for fiscal year 2025 in a Federal Register notice (FRN). This FRN publishes annual OMUFA fees and includes information about fee calculations, due dates, and payment procedures. Learn more: FRN ?? https://lnkd.in/eqagFDeB FDA’s OMUFA webpage ?? https://lnkd.in/eCUeY2dJ
Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the FDA is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply. https://lnkd.in/eUW-a2pb The FDA is announcing a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of the sole source of nutrition for formula-fed babies and children remains available for one of our nation’s most vulnerable populations.
The FDA has added hemodialysis bloodlines (product code FJK) to the Medical Device Shortages List. The agency has also determined that the shortages of blood culture media bottles (product code MDB) and Container, I.V. (product code KPE) are resolved and have been removed them from the MDSL. Find out more: https://lnkd.in/e73XMJTG
Today we are releasing interim results of FDA’s ongoing sampling of 60-day aged raw milk cheese. Of those 110 samples collected to date, 96 were negative by PCR (meaning that H5N1 was not detected in the analyzed samples), and 14 are still in progress. Final results are expected later this spring. In addition, we’re previewing research results from an FDA-funded Cornell study suggesting the 60-day aging process alone may not be effective in eliminating viable H5N1 virus in raw milk cheese. Note: additional studies have confirmed that pasteurization inactivates the virus. Consumers should check the product label to see if a product has been made with raw or pasteurized milk. https://lnkd.in/dHegjp2J
Today, the peer-reviewed scientific journal American Journal of Preventive Medicine published a study co-authored by FDA scientists showing that the agency’s youth e-cigarette prevention campaign, “The Real Cost,” prevented an estimated 444,252 American youth from starting to use e-cigarettes between 2023 and 2024. https://lnkd.in/eWcGWhKP
FDA转发了
I am directing the FDA commissioner to start the process of changing the rules to eliminate the self-affirmed GRAS pathway for new ingredients. I am also calling on the FDA and NIH to continue to conduct and improve post-market assessments of GRAS chemicals currently in our food so we can rapidly identify the compounds that are making Americans so sick, and so that American consumers and regulators can make informed decisions. This is an important step in our pursuit to Make America Healthy Again.