FDA issues a table with recommendations for medical device manufacturers to use in association with an earlier pandemic guidance on notifying the agen...
Sandoz asks the DC federal court to order FDA to set aside its award of new chemical entity status and exclusivity to Sanofi Genzymes Aubagio and to a...
The Association for Accessible Medicines raises several concerns with an FDA final guidance on controlled correspondence related to generic drug-devic...
FDA clears a Brain Scientific 510(k) for its NeuroCap device, an advanced electroencephalogram electrode array used to obtain rapid EEGs in routine cl...
GlobalData says that positive results from two Jyseleca testicular safety studies could lead to FDA approval for an indication for ulcerative colitis ...
FDA clears an Ultragenyx Pharmaceutical IND for UX053, an investigational mRNA therapy being evaluated for treating Glycogen Storage Disease Type III.
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...
CDRH announces a 4/13 workshop on how medical device developers can use consensus standards in premarket submissions.