• GDUFA Reauthorization: Time to Make Adjustments

    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.

  • FDA to Use Metrics Initiative to Improve Drug Quality throughout Supply Chain

    Combating drug quality and supply shortages are ongoing concerns for stakeholders throughout the pharmaceutical supply chain, including members of SOCMA’s Bulk Pharmaceuticals Task Force (BPTF). As a means to address these concerns, the U.S. Food and Drug Administration (FDA) is working with the pharmaceutical supply chain on a new Quality Metrics Initiative (QMI). This new initiative, which has been in the works for several years, was a key topic of discussion during the recent DCAT Week 2015 in New York.
  • BPTF Voices Concern to FDA about Reduction of Domestic Facility Inspection Frequency

    SOCMA’s Bulk Pharmaceuticals Task Force has long been an advocate and supporter of the Food and Drug Administration’s (FDA) Generic Drug User Fee (GDUFA) program and its goal to consistently perform risk-based inspections of both U.S. and foreign drug manufacturing facilities. But concerns were recently raised when a memo from the Department of Health and Human Services disclosed a 40 percent decrease in the number of inspections of U.S. drug facilities in 2014 and 2015 – a move that could significantly impact the generic active pharmaceutical ingredient (API) manufacturers the Task Force represents.

  • Could Sequestration Derail Generic Drug User Fee Program?

    With sequestration looming, SOCMA’s Bulk Pharmaceuticals Task Force is concerned the program it worked years to bring about – Generic Drug User Fees (GDUFA) – could be derailed by budget cuts set to take effect March 1. GDUFA was signed into law by President Obama in July and took effect in October.
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John DiLoreto
Executive Director
(301) 987-0924