FDA Commissioner Gottlieb testifies before the U.S. Senate Committee on Health, Education, Labor & Pensions on the agency’s implementation of the 21st Century Cures Act
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Creative Contract Packaging LLC Issues An Allergen Alert Regarding 4 Ounce Jars Of Herb-Ox® Beef Flavor Granulated Bouillon Due To Potential Presence Of Undeclared Milk
Creative Contract Packaging LLC is voluntarily recalling 4,412 cases, or 13,236 total pounds, of two code dates of HERB-OX® Beef Flavor Granulated Bouillon, due to the potential presence of an undeclared milk allergen.
Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues
Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.
FDA Alerts Consumers to Recall of Certain Comforts FOR BABY Water with Fluoride
The Kroger Company has recalled Comforts FOR BABY Purified Water with Fluoride Added 1 GAL (3.78 L) with sell by dates from 4/26/2018 to 10/10/2018, after receiving complaints about mold in the product. Testing by Kroger has identified the mold as Talaromyces penicillium. The water is sold in clear containers, but the mold may not be visible with the naked eye.
Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
The FDA is issuing final guidance on the technical considerations for the 3D printing of medical devices. The recommendations clarify what the FDA recommends manufacturers include in submissions for 3D printed medical products.
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments
Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages
Statement by FDA Commissioner Scott Gottlieb, M.D. on efforts by the agency to address the impact of IV saline products and amino acids for injection shortages following the hurricane and update on FDA’s work in Puerto Rico