Two Sheppard Mullin attorneys say that mHealth app developers need to be aware that they must meet sometimes conflicting state and federal requirement...
FDA approves a Supernus Pharmaceuticals supplemental NDA for a a label expansion for Trokendi XR (topiramate) to include migraine headache prevention ...
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.