FDA issues a draft guidance on Information Requests and Discipline Review Letters Under GDUFA that outlines how such letters will be used during the A...
FDA improves transparency in a revised listing that identifies brand drugs that do not have any generic competition.
FDA releases a draft guidance on Investigational IVD Used in Clinical Investigations of Therapeutic Products to help researchers involved in precision...
FDA lifts a clinical hold on Alnylam Pharmaceuticals clinical studies with fitusiran, indicated for treating patients with hemophilia.
Federal Register notice: FDA makes available a draft guidance entitled The Least Burdensome Provisions: Concept and Principles that intends to elimina...
Federal Register notice: FDA issues a priority review voucher to Ultragenyx Pharmaceutical for obtaining approval of a rare pediatric disease product ...
Federal Register correction notice: FDA corrects an 11/27 notice entitled Safety Assessment for Investigational New Drug Safety Reporting; Public Work...
Citing correspondence addressed to then-new commissioner Scott Gottlieb, the Project On Government Oversight questions how biotech executive John F. C...