Food and Drug Administration

Drug Safety and Risk Management Advisory Committee


Briefing Information


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Background Index  doc  htm  pdf

34 Year Overview of Patient Information and FDA  pdf

Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001 - Final Report to DHHS, Dr. Bonnie Svarstad, PhD, U. of Wisconsin  doc  htm  pdf

Final Report Appendices  doc  htm  pdf

Final Report Tables doc

Information Advisory  pdf

Public Law 104-180 Sec 601 Effective Medication Guides  pdf

Success of Private Sector Patient Information With Prescription Medicines htm