Readers had a lot to say about my latest column on the Food and Drug Administration’s proposed front-of-package labels. Most ...
The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
The Lay’s potato chips recall for undeclared milk was upgraded to the FDA’s highest risk level. Find out what this means for ...
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...
The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and ...
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 ...
A recall of a Pinsarella Roman Pizza product from Pinsarella Food has been classified as a Class I recall by the U.S. Food and Drug Administration (FDA) due to undeclared wheat and soy.
Barclays has sounded the alarm over a letter going out to customers, after a complaint from an individual regarding a change to their account. The customer reached out to the bank on social media ...
After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has publicly laid out its reasoning for rejecting Vanda Pharmaceuticals’ ...
The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for Epstein-Barr virus–positive post-transplant lymphoproliferative disease ...
With 2024 ending, the FDA has tabulated more than 3,500 warning letters (as of mid-December) by a variety of federal offices, including the Office of Regulatory Affairs and the Center for Drug ...
US Judge Blocks FDA Graphic Warning Label Requirement for Cigarettes By Nate Raymond (Reuters) - A federal judge in Texas has blocked the U.S. Food and Drug Administration from enforcing a looming ...