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GDUFA Reauthorization: Time to Make Adjustments

Posted: 08/26/15 at 5:05 PM

By John DiLoreto, Executive Director, Bulk Pharmaceuticals Task Force

One of life’s certainties is that things don’t always go according to plan. SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) and other industry stakeholders worked for several months to negotiate the original Generic Drug User Fee Act (GDUFA). Ideas were shared, resources were estimated, commitments were made, and finally, an act of Congress made it the law.

In the end, the tradeoff was quite simple. The Food and Drug Administration (FDA) would immediately begin to implement certain efficiencies, lay the groundwork for full implementation for the new user fee program, and begin hiring nearly 1,000 new staffers to carry out the program. In exchange, Active Pharm...

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The Demographic Crossroads – Interesting Insights into America’s Future

Posted: 08/03/15 at 8:15 AM

By Jenny Gaines, Senior Manager, Communications and Public Relations

When most of us think about what will have the greatest impact on our future, we first think about money. And over the past decade, we have heard economists give us varying reports ranging from gloom and doom to hopeful optimism. Very few times do we stop and think about how the number of children being born, or not being born, in various countries will impact what’s to come for our nation and the world.

During the recent Bio-Process Systems Alliance (BPSA) 2015 International Single-Use Summit author and speaker Kenneth W. Gronbach shared his perspective about our nation’s future based on demographic data. His presentation (taken from his book), “The Age Curve – How to Profit from the Coming Demographic Storm,” was part of his keynote address to more than 100 attendees.

Gronbach showed how demographics will impact everything from the housing market and economy to funerals and the pharmaceutical industry, which really ca...

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CFATS–Hitting Its Stride

Posted: 07/20/15 at 8:00 AM

By David Wulf, Director of the Infrastructure Security Compliance Division, the office within the Office of Infrastructure Protection at the Department of Homeland Security  (DHS) that houses the Chemical Facility Anti-Terrorism Standards (CFATS) program

I would like to start by thanking SOCMA for the opportunity to reach its membership of specialty chemical manufacturers, a segment of the population regulated by the Chemical Facility Anti-Terrorism Standards program that—along with SOCMA—has been very supportive of promoting chemical security across the Nation.  

Once again, the Department of Homeland Security is co-sponsoring the annual Chemical Sector Security Summit with the Chemical Sector Coordinating Council on July 21–23, 2015—an effort in which SOCMA has played an in...

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