STAT10d
Sanofi is warned by the FDA over ‘significant’ problems at a key manufacturing plant
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...
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.
Becker's Hospital Review1d
FDA warns GLP-1 compounder over safety rules
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...
Pharm Exec3d
Challenges to Navigating the Pharmaceutical Regulatory Landscape
In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...
Lay’s Potato Chip Recall Increased to Highest Risk Level, FDA Warns Product Could Cause 'Death’
Lay’s voluntary recall from December has been increased to the U.S. Food and Drug Administration’s highest risk level ...
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
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.
BioSpace3d
Atara to Cut Half Its Workforce Following FDA-Related Setbacks
Atara Biotherapeutics’ layoffs could leave the biotech with around 80 employees. The cuts follow news that the FDA rejected ...
BioSpace9d
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
JD Supra2d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
Popular Super Bowl snack recalled under FDA’s highest risk
Check your snacks before the Super Bowl. The Food and Drug Administration has given the highest risk classification to a ...
The FDA's recall on certain Lay's potato chips escalates to worst risk category
A previous FDA recall on certain Lay's potato chip products has now been updated to the category with the highest risk for ...