A citizen petition from PhRMA and other groups urges FDA to not approve a proposal from Colorados Department of Health Care Policy & Financing that se...
FDA reviewers question the reliability of an actual use study that was submitted to support approval of a Laboratoire HRA Pharma NDA seeking a prescri...
FDA accepts for review a Glaukos NDA for iDose TR (travoprost intraocular implant) for treating open-angle glaucoma or ocular hypertension.
Federal Register notice: FDA determines that Bayers Levitra (vardenafil HCl) oral tablets (5mg, 10mg and 20mg) were not withdrawn from sale due to saf...
Federal Register notice: FDA makes available a draft guidance entitled Decentralized Clinical Trials (DCT) for Drugs, Biological Products, and Devices...
Alleging weak evidence of effectiveness accepted by an advisory committee, Public Citizen calls on FDA to reject an Otsuka/Lundbeck sNDA for Rexulti t...
The Government Accountability Office says the National Institutes of Health should instruct its research and development grant awardees to name NIH an...
Xortx says a meeting with FDA staff provided the information needed to initiate a Phase 3 study of its Xorlo to treat autosomal dominant polycystic ki...
