FDA expands the approved use of GlaxoSmithKlines Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis.
Federal Register notice: FDA seeks comments on an information collection extension for Orphan Products Development; FDA Orphan Drug Designation Reques...
CDRH outlines steps it is taking to improve and expand use of patient-reported outcomes in regulatory proceedings.
AdvaMed recommends ways to improve CDRHs voluntary medical device manufacturing and product quality program.
Federal Register notice: FDA announces the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal...
Federal Register notice: FDA makes available a guidance entitled Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisemen...
FDA releases its latest batch of Warning Letters that includes Fagron Compounding Services, RC Outsourcing and Seindni Co.
Federal Register notice: FDA seeks comments on an information collection extension for FDA Application for Participation in FDA Fellowship Programs (F...