Author Archives: Jill Wechsler

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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Vaccine Demand Spurs Innovation

Vaccine development is on a roll, boosted by biomedical research uncovering new molecular targets for preventives and treatments, as well as innovative techniques for enhancing vaccine potency and production. There is high demand for new vaccines to prevent deadly tropical diseases, illustrated by the recent Ebola virus outbreak, and for capacity to respond quickly to […]
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FDA Takes First Amendment Issues "Seriously"

Several legal cases have challenged the Food and Drug Administration’s approach to regulating industry communications about medical products, and agency officials now are acknowledging the importance of addressing these developments head-on. In the wake of U.S. v. Caronia and IMS v. Sorrell, the spotlight is on speech-related activity, including product labeling and advertising and promotion […]
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US Pharmacopeia Head Wants Fresh Outlook

In anticipation of the 200th anniversary of the United States Pharmacopeia (USP) in 2020, the organization’s new leadership is taking a fresh look at its role in setting standards for pharmaceutical development and production and how that has been altered by new regulatory policies and industry globalization. USP chief executive officer Ron Piervincenzi is consulting […]
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