Faced with harsh criticism from Democrats about his ties to regulated industry, FDA commissioner nominee Scott Gottlieb tells members of the Senate He...
Yale School of Medicine cardiologist Harlan Krumholz says shortcuts to drug approvals such as using surrogate endpoints can increase patient risk and ...
A Foley online guide lists six steps for life sciences and medical device companies to protect proprietary data and intellectual property assets from ...
Silvergate Pharmaceuticals asks FDA to impose specific bioequivalence requirements on any ANDA for a generic version of its antihypertensive Epaned.
PhRMA says the FDA Program for Enhanced Review Transparency and Communications has increased the likelihood of first-cycle approval for some NDAs and ...
Attorney Sheldon Bradshaw calls for stiffer penalties for drug counterfeiting and diversion.
Sen. Patty Murray asks Olympus for data demonstrating that its repaired duodenoscopes can be reprocessed effectively.
A Georgia federal judge says Hi-Tech Pharmaceutical products containing DMAA are adulterated and subject to seizure because DMAA is not a dietary ingr...