• Government Shutdown Impacting Generic Drug User Fee Program, other FDA Programs

    After almost three weeks, the government shutdown is having a ripple affect on the Food and Drug Administration’s (FDA) submission of Generic Drug User Fee Act (GDUFA) and other pharmaceutical supply chain user fee programs overseen by the Agency. 
  • BPTF Hosts Annual Spring Meeting to Discuss Issues Impacting Active Pharmaceutical Ingredient Manufacturers

    The Bulk Pharmaceuticals Task Force (BPTF) hosted its annual Spring Meeting here at the Society for Chemical Manufacturers and Affiliates (SOCMA) headquarters to discuss key issues and challenges facing the pharmaceutical industry and hear from industry experts.
  • Tariffs Hit Pharma Hard

    The Trump administration's proposed tariffs on a wide variety of imports from China include a lengthy list of chemicals used in the specialty chemical, fine chemical, and pharmaceutical industries...
  • BPTF Once Again a Key Stakeholder in Renegotiating Generic Drug User Fees

    The U.S. Senate’s approval of the Food and Drug Administration Reauthorization Act of 2017, which includes the Generic Drug User Fees (GDUFA) program, was a big win for SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) members and, ultimately, U.S. consumers and patients. GDUFA, initially enacted in 2012, is specifically designed to improve the quality and availability of drugs throughout the supply chain.
  • SOCMA’s BPTF Hails Senate Passage of Bill Reauthorizing FDA’s Generic Drug User Fees

    ARLINGTON, VA – The Society of Chemical Manufacturers and Affiliates (SOCMA) Bulk Pharmaceuticals Task Force today commends the U.S. Senate on passage of the Food and Drug Administration Reauthorization Act of 2017, which includes the Generic Drug User Fees (GDUFA) program that is designed to improve the quality and availability of drugs throughout the supply chain.
  • SOCMA’s BPTF Pleased with Outcome of Round Two of Generic Drug User Fee Negotiations

    WASHINGTON, D.C. – The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), today hailed the successful ending of negotiations for the reauthorization of the Food and Drug Administration’s (FDA’s) Generic Drug User Fee program (GDUFA).

  • 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.

  • BPTF Seeks Changes in Performance Goals, Fee Payment Schedule in GDUFA Renegotiations

    WASHINGTON,  D.C. – The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates, today asked the Food and Drug Administration (FDA) to consider several changes to performance goals and the fee payment schedule prior to reauthorization of the Generic Drug User Fee Act (GDUFA). BPTF made its requests during a public meeting in White Oak, MD.
  • 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.

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BPTF

Contact Us

John DiLoreto
Executive Director
JDiLoreto@bptf.us
(301) 987-0924