[ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher to AstraZeneca for an approved rare pediatric disease product Kosel...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Geriatric Information in Human Prescription Drug and Biolog...[ Price : $8.95]
Attorney Sara Koblitz says Californias governor is considering signing legislation that would make the state a partner in drug man...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment.[ Price : $8.95]
The DC federal court says FDA misinterpreted the FFDCA when it approved Lannetts Numbrino during the new chemical entity exclusivi...[ Price : $8.95]
Politico reports exclusively that HHS secretary Alex Azar ordered FDA to stop evaluating laboratory-developed tests over the objec...[ Price : $8.95]
FDA announces a 10/30 virtual public workshop on New Drugs Regulatory Program Modernization: Implementation of the Integrated Asse...[ Price : $8.95]
SheppardMullin attorneys say FDA seems to be years away from implementing its pilot software pre-certification program.