Woodcock: FDA Will Release Several Drug Safety Guidances This Fall

摘要

The FDA plans to release several drug safety guidances this fall, including one on safety-related labeling changes, a top FDA official says.rnOther guidances will cover postmarketing studies and clinical trials, MedGuide-only risk evaluation and mitigation strategies (REMS), and the biomarker qualification process, CDER Director Janet Woodcock said Oct. 18 at FDAnews' Third Annual Risk Management and Drug Safety Summit in Washington.