Drugs

ICH M14 Pharmacoepidemiological Studies Guide

FDA has published a draft International Conference on Harmonization M14 guidance, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines, to recommend international standards for, and promote harmonization of, the general principles on planning, designing, and analyzing observational pharmacoepidemiological studies that use fit-for-purpose data for safety assessment of medicines. The document outlines recommendations and high-level best practices for the conduct of the studies, to streamline the development and regulatory assessment of study protocols and reports.

“These recommendations and practices also seek to improve the ability of the study protocol and/or results to be accepted across health authorities and support decision-making in response to study results,” the guidance says.

The draft contains an Introduction, General Principles, Framework for Generating Adequate Evidence Using Real-World Data, Initial Design and Feasibility, Protocol Development, Data Management, Analysis, Reporting and Submission, Dissemination and Communication of Study Materials and Findings, Study Documentation and Record Retention, Considerations in Specific Populations, Glossary, Regulation Guidelines Referenced, Non-Regulatory Guidelines Referenced, and References.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome