Halted research, disciplined doctors: internal audit finds Kaiser ignored patient protections in California study
Two top clinicians have been disciplined amid growing concern that Kaiser’s system for monitoring research safety and ethics ...
Acsh.org2d
FDA’s Failures in the Infant Formula Debacle Cry Out for Reform
There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as ...
Colorado Public Radio13d
FDA finds multiple health violations at Colorado Springs-based food processing facility linked to fatal E. coli outbreak
The October 2024 outbreak sickened at least 49 people nationwide, most of whom were in Colorado. One resident of Mesa County ...
Becker's Hospital Review8d
FDA warns Sanofi over manufacturing violations
The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...
Baking Business13d
Report: FDA needs to improve food inspection
WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the ...
Food Safety News3d
FDA warns bakery for food safety violations, including sanitation and allergen control failures
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...
FiercePharma9d
Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection
After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...
JD Supra1d
FDA Broadens Oversight of Lab-Developed Tests
Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and ...
FiercePharma9d
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...
Food Safety News7d
Government Accountability Office finds problems with FDA inspection rates
In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities ...