This post was written by Paul Shieves.
The FDA is seeking comments on a draft guidance document entitled “Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.” The guidance provides recommendations for documenting the design, analysis, and results of pharmacoepidemiologic safety studies to optimize FDA’s review of protocols and final reports for such studies. Comments are due April 18, 2011. FDA also has issued draft guidance on “Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.” The guidance seeks to aid manufacturers engaged in new drug development by addressing how variations in the human genome could affect the clinical pharmacology and clinical responses of drugs. The guidance provides recommendations on when genomic information should be considered to address questions arising during drug development and regulatory review, and provides advice on general principles of study design, data collection, and data analysis. FDA is accepting comments on the document until April 19, 2011. Finally, a draft guidance document on “Medication Guides–Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)” addresses when a medication guide will be required as part of a REMS program. It also discusses when FDA intends to exercise enforcement discretion regarding when a medication guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient, instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient. Comments are due May 31, 2011.