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A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety...[ Price : $8.95]
A Yale Journal on Regulation article from the Yale Law School Solomon Center for Health Law & Policy examines how the Supreme Cour...[ Price : $8.95]
FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.[ Price : $8.95]
FDA warns Japans Sato Pharmaceutical Co. about CGMP violations in its production of finished over-the-counter drugs.[ Price : $8.95]
The U.S. government urges the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whe...[ Price : $8.95]
Outlook Therapeutics wins an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path towa...[ Price : $8.95]
FDA investigators cite major quality control and data integrity concerns at an Indian manufacturing facility operated by Intas Pha...[ Price : $8.95]
Dyne Therapeutics submits a BLA that seeks accelerated approval for its experimental Duchenne muscular dystrophy therapy z-rostudi...