[ Price : $8.95]
A Goldwater Institute investigative report faults FDA caution in approving new drugs, saying it stifles innovation and leads to un...[ Price : $8.95]
FDA declines a BioElectronics 510(k) submission for its ActiPatch, seeking expanded over-the-counter indications for treating musc...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that include The Delano Co. and Mylan Pharmaceuticals.[ Price : $8.95]
Six drug company stakeholders ask FDA for changes to an agency draft guidance on post-approval changes to drug substances.[ Price : $8.95]
Hyman, Phelps & McNamara asks FDA not to approve a Zelnorm sNDA without substantial evidence of safety and efficacy under currentl...[ Price : $8.95]
Synaptive Medical recalls its BrightMatter Guide with SurfaceTrace Registration due to a software defect that could potentially re...[ Price : $8.95]
FDA warns Mylan about CGMP violations at its Morgantown, WV, drug manufacturing facility.[ Price : $8.95]
FDA accepts for review a Biohaven Pharmaceutical Holding Co. 505(b)(2) NDA for BHV-0223, an investigational sublingual form of ril...