She described her cousin's basement, garage and dorm as being an epicenter for drug use, where he would also put baby ...
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 ...
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even though the company recalled the devices last year.
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...
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