dermatologyadvisor2d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
Sanofi’s Framingham facility hit with FDA warning
French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham.
Becker's Hospital Review9d
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, ...
FiercePharma10d
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 ...
CBS News15d
How food brands and drugmakers are responding to FDA's ban of food dye Red 3
The FDA says that food companies will have until Jan. 15, 2027 to stop using the dye. Drugmakers will have an extra year, until January 2028, to comply with the change. Red 3, also known as ...
Forbes15d
FDA’s Red Dye No. 3 Ban, Explained—What It Means For Food And Trust
Red Dye No. 3, or erythrosine, is a synthetic red food dye once popular in candies and cakes. The ... [+] FDA bans Red Dye No. 3 under the Delaney Clause, citing cancer risks observed in lab ...
Al Jazeera English16d
What is Red Dye 3 and why has the US FDA banned it in food and drinks?
On Wednesday, the Food and Drug Administration (FDA) proscribed the dye based on a 2022 petition by consumer advocacy groups against its use, which had already been banned in cosmetics 35 years ago.
ScienceAlert16d
FDA Finally Outlaws Red Food Dye Banned Around The World
"FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No 3 in the color additive regulations," said a document from the Department of Health and Human Services, published in the ...
ABC News17d
FDA bans red dye No. 3 from foods
Officials cited a statute known as the Delaney Clause, which requires FDA to ban any additive found to cause cancer in people or animals. The dye is known as erythrosine, FD&C Red No. 3 or Red 3.
BioSpace17d
Izotropic Announces Team Leading Clinical Study Design and FDA Regulatory Submissions
New FDA Consultant is the former Director of the Division of Imaging ... C.R Bard, Smiths Medical, ACMI, Genzyme, Pfizer Hospital Products, and various start-ups. He is the former VP of Regulatory ...
CBS News17d
Food shoppers could see nutrition facts on the front, as FDA unveils proposed packaging rules
FDA's new "nutrition info box" focuses on telling people whether levels of saturated fat, sodium and added sugar are "high" or "medium" or "low" as well as the percentage for each serving.
Nature1mon
2024 FDA approvals
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...