[ Price : $8.95]
CDER asks an FDA hearing officer to direct Covis to provide additional information on items from its final briefing materials for ...[ Price : $8.95]
GlaxoSmithKline says its investigational adult respiratory syncytial virus vaccine candidate was highly effective in a Phase 3 tri...[ Price : $8.95]
FDA says Teva manufacturing delays have led to a shortage of Adderalls immediate-release formulation.[ Price : $8.95]
FDA publishes a final guidance on using comparability protocols for postapproval changes in chemistry, manufacturing, and controls...[ Price : $8.95]
FDA solicits input on a discussion paper raising regulatory issues and questions about direct manufacturing and point-of-care manu...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says it wants to research how consumers and healthcare providers interpret prescrip...[ Price : $8.95]
FDA says Palm Harbor, FL-based Regener-Eyes is illegally marketing its Regener-Eyes Ophthalmic Solution.[ Price : $8.95]
Federal Register notice: FDA extends the comment period for a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK...