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The latest news from HMD, including information about new reports, activities, meetings, and other noteworthy events.

News Release

Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA's Oversight of Approved Drugs' Safety
Released: 5/1/2012

Although the approval of a new drug is based on evidence that its benefits outweigh its risks, the full range of a medication's effects may not become apparent until a product has been used by a larger, more diverse population over an extended period of time. Problems associated with the anti-diabetes drug Avandia, pain reliever Vioxx, and cholesterol-reducing drug Crestor illustrate the challenges and underscore the need for a more systematic and transparent process to collect, assess, and act on data about a medication's benefit-risk profile throughout its entire "life cycle" from approval until it is no longer marketed, says a new report by the Institute of Medicine.

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News Release

Report Offers FDA A Framework for Evaluating Ethical Issues When Deciding Whether to Require Postmarketing Studies of Drugs
Released: 7/9/2010

A new letter report from the IOM recommends a conceptual framework to help the U.S. Food and Drug Administration evaluate the ethical issues involved in determining whether companies should start or continue clinical trials on approved drugs and in ensuring that these studies are ethically conducted. FDA has recently gained enhanced authority to require drug companies to undertake studies of their products after they are put on the market, which presents the agency with additional challenges.

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