[ Price : $8.95]
FDA schedules a 9/1 joint advisory committee meeting to discuss Collegium Pharmaceuticals NDA for Xtampza for managing pain severe...[ Price : $8.95]
Federal Register Notice: FDA corrects a 7/31 Federal Register notice on modified risk tobacco product applications from Swedish Ma...[ Price : $8.95]
A New York federal court rules in Amarins favor in its First Amendment-based complaint that FDAs regulations are unconstitutional ...[ Price : $8.95]
FDA and TiGenix NV have reached agreement on a Special Protocol Assessment (SPA) for a Phase 3 registration trial involving Cx601 ...[ Price : $8.95]
The Association for Molecular Pathology proposes changes it says will modernize CLIA regulations and address oversight of laborato...[ Price : $8.95]
FDA and HHS staffers propose a new model to speed testing and review of investigational drugs during public health emergencies.[ Price : $8.95]
Two Venable attorneys urge companies regulated by FDA to fully respond to agency concerns expressed in Warning Letters and other c...[ Price : $8.95]
Otsuka answers an Alkermes response to an Otsuka petition asking that FDA not approve an Alkermes NDA for a drug that is similar t...