SYS-CON MEDIA Authors: Mat Mathews, Newswire, David Smith, Tim Crawford, Kevin Benedict

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FDA Grants Request for Waiver of PDUFA Fees

DETROIT, Feb. 11, 2014 /PRNewswire/ -- VPCI, Inc., a provider of consultation services to the pharmaceutical industry, is pleased to announce the collection of additional reimbursements from the U.S. Food and Drug Administration (FDA) resulting from PDUFA fee waiver requests.  In a fairly narrow set of qualifying circumstances, drug manufacturers may qualify for refunds of PDUFA fees paid.  Continuing to act on behalf of its clients, VPCI provided assistance and coordinated the entire refund claim throughout the two-year process.  The refunds received relate to FY2012 PDUFA fees.

"We are always looking for additional ways to benefit our clients," said Craig Kruman, CFO and Director of Regulatory Administration for VPCI.  "We have identified several companies that were not claiming refunds of money due to them from the FDA.  Maybe it was a lack of understanding of the regulations or an accidental oversight, but through our guidance throughout the process our clients were awarded substantial refunds of PDUFA fees paid."

Craig Kruman further went on to explain, "We advise all our clients to review their situation in respect to PDUFA fees.  Due to strict filing timelines imposed by the FDA, if an opportunity to file for refund is missed, that money will generally be gone forever.  It would be a shame not to take advantage of this opportunity within the PDUFA regulations.  A consultant knowledgeable in this area is essential."

About VPCI
VPCI, Inc. (Vectech Pharmaceutical Consultants International) (  is a Pharmaceutical consulting firm that offers FDA regulatory guidance, manufacturing technology support, and high-level business development services.  With a global network of scientific and technical experts, VPCI has a broad ability to serve its clients dealing with a number of regulatory agencies.  VPCI offers audits and training to manufacturers, strictly following good manufacturing practices (GMP).


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