FDA encourages stakeholders who are developing drugs containing cannabis to consider using the drug master file pathway to protect proprietary informa...
Federal Register notice: FDA issues a priority review voucher to AstraZeneca for an approved rare pediatric disease product Koselugo (selumetinib).
Federal Register notice: FDA makes available a draft guidance entitled Geriatric Information in Human Prescription Drug and Biological Product Labelin...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 ...