FDA Releases Final Guidance On External Clinical Study Monitors
This article was originally published in The Gray Sheet
Executive Summary
Final guidance issued by FDA March 28 acknowledges device company concerns about the burden of clinical trial data monitoring committees, but stops short of acquiescing to requests to substantially change its 2001 draft recommendations
You may also be interested in...
Data Monitoring Should Be Tailored To Device Trial Needs – Manufacturers
FDA's guidance on clinical trial data monitoring committees (DMCs) should make clear that device firms need not hire independent statisticians to perform interim analyses, Medtronic writes in Feb. 15 comments to FDA regarding the November 2001 draft guidance
Data Monitoring Committees Are Useful For High-Risk Phase I/II Trials – FDA
FDA strongly recommends data monitoring committees for early-phase clinical trials where the investigator is also the sponsor, or where subjects may be placed at unusual risk, a Nov. 16 draft guidance on DMCs states
Probiotics And Cold Remedies Boost Recordati In 2023
Italy's Recordati saw its OTC sales grow by 10% in 2023 driven by the recovery of the cough & cold market and a growing demand for probiotics.