Jun 15, 2020
FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
Apr 16, 2020
Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
Mar 11, 2020
U.S. Medical Devices Regulatory Intelligence Report 2020
Feb 03, 2020
Emergo by UL launches 510(k) Builder for streamlined US FDA medical device submissions
Dec 10, 2019
FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations
Nov 26, 2019
California-based food manufacturer agrees to stop production after repeated food safety violations
Sep 19, 2019
FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program
Sep 03, 2019
Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations
Jul 18, 2019
Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions
Jun 05, 2019
Two Day FDA Approval Process for Medical Devices Seminar: Gain an Understanding of the Underlying Legal and Regulatory Requirements - London, United Kingdom - September 16-17, 2019
May 22, 2019
Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions
Jan 30, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's efforts to enhance the utility of the Orange Book to foster drug competition
Nov 29, 2018
FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency's ongoing Youth Tobacco Prevention Plan
Nov 20, 2018
FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder
Nov 09, 2018
FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse
Oct 02, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter 'gaming' of the generic drug approval process by the use of citizen petitions
Sep 07, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states
Aug 30, 2018
District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs
Aug 15, 2018
Endo Lifts Temporary Stay of FDA Litigation Following the Launch of a Bulk-Compounded Vasopressin Product by a Section 503B Outsourcing Facility
Jun 08, 2018
Federal judge enters consent decree against Delta Pharma