The trouble with those post-marketing studies required by the FDA

first_img Ed Silverman Pharmalot @Pharmalot What’s included? To ensure a new drug works properly after marketing approval is granted, the Food and Drug Administration regularly requires a drug company to run a so-called post-marketing study. But a new analysis found a troubling lack of timely follow-through as well as basic information.Specifically, one in four studies was never publicly disseminated. Meanwhile, there was often little information about post-marketing requirements — the median description was just 44 words — and some were difficult to categorize. There was also a lack of up-to-date information on the progress of about one-third of these study requirements. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Andrew Harnik/AP What is it? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Log In | Learn More center_img GET STARTED Tags pharmaceuticalspolicyresearchSTAT+ [email protected] By Ed Silverman June 12, 2018 Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. About the Author Reprints The trouble with those post-marketing studies required by the FDA Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTEDlast_img read more