Federal Register notice: FDA makes available a draft guidance entitled Geriatric Information in Human Prescription Drug and Biological Product Labelin...
Attorney Sara Koblitz says Californias governor is considering signing legislation that would make the state a partner in drug manufacturing and distr...
Federal Register notice: FDA makes available a final guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment.
The DC federal court says FDA misinterpreted the FFDCA when it approved Lannetts Numbrino during the new chemical entity exclusivity period for Genus ...
Politico reports exclusively that HHS secretary Alex Azar ordered FDA to stop evaluating laboratory-developed tests over the objections of commissione...
FDA announces a 10/30 virtual public workshop on New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing ...
SheppardMullin attorneys say FDA seems to be years away from implementing its pilot software pre-certification program.
FDA classifies as Class 1 a recall involving a Becton Dickinson CareFusion recall of its Alaris Syringe and Alaris PCA Modules due to potential incorr...