Risk Management Shapes FDA Policies and Practices

In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.

Related Content:

Quality SystemsRegulatory WatchPharmaceutical Technology-08-02-2002

Gilead Treatment for PBC Granted EC Conditional Marketing Authorization

Ask the Expert: Complying with 21 CFR 211.110

FDA Grants Full Approval for Symptomatic Tenosynovial Giant Cell Tumor Treatment