Category Archives: People

New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman

‘Actions’ don’t speak louder than words in dealing with FDA’s backlog of generic drug applications, says newly-elected GPhA Board Chairman Craig Wheeler. When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process […]
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New Faces of Patient Advocacy

In this short video, Brianna Cayo-Cotter, Change.org’s managing director of communications, talks to Pharm Exec about how advocacy organizations and individual patients are getting more involved in every facet of the healthcare system, from drug R&D, to federal and state policy, all fueled by the hour-to-hour passion of living with a disease.
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HBA's 2014 Woman of the Year: Broadening the Base

HBA’s 2014 Woman of the Year:  Broadening the Base To mark its 25th year in recognizing female leadership in the tough competitive ranks of biopharma, the Healthcare Businesswomen’s Association [HBA] is opting for a breakout triple play.  When the group convenes on May 1 in New York for its annual Woman of the Year [WOTY] […]
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The Changing Face of Patient Advocacy

Pleas for compassionate use access are on the increase, and Change.org is giving patients an audience. In THE ACTIVE PATIENT: FACES OF CHANGE, PharmExec’s feature story, Brianna Cayo-Cotter, Change.org’s managing director of communications, says one successful petition often begets another. Politicians and celebrities, in unprecedented fashion, are coming out in support of compassionate use petitions. […]
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Compliance Congress: Walking the Line

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.
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