Author Archives: Jill Wechsler

Experts Tell Congress How to Streamline Clinical Trials

Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process, according to leaders of biopharmaceutical research community. As part of its 21st Century Cures Initiative, the House Energy & Commerce Committee called on representatives of industry and academia to present strategies for reducing regulatory oversight, speeding up […]
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Will the Supreme Court Spur OTC Contraceptive Development?

One piece of fall-out from the recent Hobby Lobby decision by the U.S. Supreme Court is to generate talk of Republicans backing development of a nonprescription contraceptive pill. Conservative commentators supported this strategy as a way for Republicans to deflect Democratic charges of a GOP “war on women” and access to safe and effective birth […]
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US Regulators and Industry Bodies Push Forward with Global Expansion

At the annual meeting of the Food and Drug Law Institute (FDLI) this year, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. In addition to conducting more inspections and oversight of […]
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Supplier Audit Program Marks Progress

The Rx360 pharmaceutical supply chain consortium celebrated its first five years with an anniversary conference on June 5  in Washington, D.C., featuring key FDA officials and industry leaders. This collaborative effort to streamline and coordinate manufacturer audits of ingredient suppliers was launched in 2009 in response to the heparin adulteration crisis, which raised broad concerns […]
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Things Looking Up for Obamacare, But New HHS Chief Faces Tough 2015

This blog previously ran on Managed Healthcare Executive. The Obama administration received a substantial amount of good news last month. Not only did 8 million individuals enroll in qualified health plans, millions more joined Medicaid or obtained coverage through private markets. Additionally, health reform will cost $100 billion less than anticipated, according to the Congressional […]
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