By Steven J. Gonzalez — On September 27, 2024, in U.S. v. California Stem Cell Treatment Center...
Category - News
Skinny-Label Lives to See Another Day
By Sara W. Koblitz — Further talks of the Skinny Label’s demise may be premature, as...
Bring Out Your Meds! Bring Out Your Meds!
Homeopathic Industry Group Wants Court to Exclude It From FDA’s Enforcement Plans
A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes
FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development
A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?
Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government
Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices