Food and Drug Administration

Science Board to the Food and Drug Administration

April 15, 2005

Briefing Information

Guidance for Industry - Premarketing Risk Assessment (PDF)

Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF)

Guidance for Industry - Development and Use of Risk Minimization Action Plan (PDF)

Guidance for Industry - Sterile Drug Products Produced by Asptic Processing - Current Good Manufacturing Practice (PDF)

Guidance for Industry - Quality Systems Aproach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF)

Reviewer Guidance - Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (PDF)