A Miami grand jury charges three defendants for their roles in an alleged scheme to fabricate and falsify clinical drug trial data submitted to FDA.
FDA publishes the International Council for Harmonization E19 guideline on selective safety data collection in some circumstances.
CDER asks an FDA hearing officer to direct Covis to provide additional information on items from its final briefing materials for an upcoming hearing ...
GlaxoSmithKline says its investigational adult respiratory syncytial virus vaccine candidate was highly effective in a Phase 3 trial, with a favorable...
FDA says Teva manufacturing delays have led to a shortage of Adderalls immediate-release formulation.
FDA publishes a final guidance on using comparability protocols for postapproval changes in chemistry, manufacturing, and controls information in NDAs...
FDA solicits input on a discussion paper raising regulatory issues and questions about direct manufacturing and point-of-care manufacturing of drugs.
The CDER Office of Prescription Drug Promotion says it wants to research how consumers and healthcare providers interpret prescription drug names.
