Commissioner Scott Gottlieb says FDA ramps up its efforts to improve the process for developing generic copies of complex drugs.
An FDA safety alert warns that dietary supplements containing biotin (vitamin B7) can cause clinically significant incorrect lab test results.
FDA releases its latest batch of Warning Letters that includes Dae Young Foods Co. and JMA Partners, Inc.
A Tufts Center for the Study of Drug Development roundtable discussion finds that innovative biologics manufacturing is cutting companies production c...
Federal Register notice: FDA seeks comments on an information collection extension for Electronic Records; Electronic Signatures OMB Control Number 09...
BioMarin Pharmaceutical agrees to sell for $125 million its Rare Pediatric Disease Priority Review Voucher it was awarded by FDA in April when it rece...
Regeneron Pharmaceuticals says two Phase 2 studies looking at adding investigational drug nesvacumab to the companys already-approved Eylea (afliberce...
Federal Register notice: FDA seeks comments on an information collection extension for Export of FDA-Regulated Products: Export Certificates OMB Contr...