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FDA grants Arena Pharmaceuticals a fast track designation for APD418, a β3-adrenergic receptor antagonist and cardiac myotrop...[ Price : $8.95]
FDA denies an Otsuka petition asking that it determine that the companys Samsca was withdrawn for reasons of safety and that no ge...[ Price : $8.95]
Eye on FDA says the CDER Office of Prescription Drug Promotion issued 10 enforcement letters in 2019 with 21 violations in 11 comm...[ Price : $8.95]
ResMed Corp. (San Diego, CA) agrees to pay more than $37.5 million to resolve alleged False Claims Act violations for paying kickb...[ Price : $8.95]
CDRH director Jeffrey Shuren says customers should follow a Cardinal Health recommendation not to use lots of Level 3 surgical gow...[ Price : $8.95]
FDA posts information about the 2018 Right to Try law and how certain patients may be able to access unapproved drugs and biologic...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Pediatric Study Plans for Oncology Drugs: Questions and Ans...[ Price : $8.95]
Attorneys Jeffrey Gibbs and McKenzie Cato say that FDA advisory committee meetings to review product applications may become a thi...