FDA Grants Request for Waiver of PDUFA Fees - KTRE.com | Lufkin and Nacogdoches, Texas

FDA Grants Request for Waiver of PDUFA Fees

  • Latest Health NewsThe Latest from HealthDayMore>>

  • Spouse's sunny outlook may be good for your health

    Spouse's sunny outlook may be good for your health

    Marriage vows often include the promise to stick together for better or for worse, and research now suggests that when it comes to your health, having an optimistic spouse is better.More >>
    Marriage vows often include the promise to stick together for better or for worse, and research now suggests that when it comes to your health, having an optimistic spouse is better.More >>
  • Mental illness not a driving force behind crime

    Mental illness not a driving force behind crime

    TUESDAY, April 22, 2014 (HealthDay News) -- Less than 10 percent of crimes committed by mentally ill people are directly linked to the symptoms of their disorders, a new study shows. "When we hear about crimes committed by people with mental illness, they tend to be big headline-making crimes, so they get stuck in people's heads," said study author Jillian Peterson, a psychology professor at Normandale Community College in Bloomington, Minn. "The vast majority of people with mental illness a...More >>
    TUESDAY, April 22, 2014 (HealthDay News) -- Less than 10 percent of crimes committed by mentally ill people are directly linked to the symptoms of their disorders, a new study shows. "When we hear about crimes committed by people with mental illness, they tend to be big headline-making crimes, so they get stuck in people's heads," said study author Jillian Peterson, a psychology professor at Normandale Community College in Bloomington, Minn. "The vast majority of people with mental illness a...More >>
  • A little wine might help kidneys stay healthy

    A little wine might help kidneys stay healthy

    An occasional glass of wine might help keep your kidneys healthy, new research suggests.More >>
    An occasional glass of wine might help keep your kidneys healthy, new research suggests.More >>
  • HealthMore>>

  • People seek out health info when famous person dies

    People seek out health info when famous person dies

    WEDNESDAY, April 23, 2014 (HealthDay News) -- The deaths of well-known people offer an opportunity to educate the general public about disease detection and prevention, a new study suggests. Researchers surveyed 1,400 American men and women after Apple co-founder Steve Jobs died of pancreatic cancer in 2011 and learned that more than one-third of them sought information about his cause of death or information about cancer in general soon after his death was reported. About 7 percent of th...More >>
    WEDNESDAY, April 23, 2014 (HealthDay News) -- The deaths of well-known people offer an opportunity to educate the general public about disease detection and prevention, a new study suggests. Researchers surveyed 1,400 American men and women after Apple co-founder Steve Jobs died of pancreatic cancer in 2011 and learned that more than one-third of them sought information about his cause of death or information about cancer in general soon after his death was reported. About 7 percent of th...More >>
  • Spouse's sunny outlook may be good for your health

    Spouse's sunny outlook may be good for your health

    Marriage vows often include the promise to stick together for better or for worse, and research now suggests that when it comes to your health, having an optimistic spouse is better.More >>
    Marriage vows often include the promise to stick together for better or for worse, and research now suggests that when it comes to your health, having an optimistic spouse is better.More >>
  • Mental illness not a driving force behind crime

    Mental illness not a driving force behind crime

    TUESDAY, April 22, 2014 (HealthDay News) -- Less than 10 percent of crimes committed by mentally ill people are directly linked to the symptoms of their disorders, a new study shows. "When we hear about crimes committed by people with mental illness, they tend to be big headline-making crimes, so they get stuck in people's heads," said study author Jillian Peterson, a psychology professor at Normandale Community College in Bloomington, Minn. "The vast majority of people with mental illness a...More >>
    TUESDAY, April 22, 2014 (HealthDay News) -- Less than 10 percent of crimes committed by mentally ill people are directly linked to the symptoms of their disorders, a new study shows. "When we hear about crimes committed by people with mental illness, they tend to be big headline-making crimes, so they get stuck in people's heads," said study author Jillian Peterson, a psychology professor at Normandale Community College in Bloomington, Minn. "The vast majority of people with mental illness a...More >>

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.

SOURCE VPCI, Inc.

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) (www.vpcint.com)  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).

©2012 PR Newswire. All Rights Reserved.

Powered by WorldNow
KTRE logo

KTRE

358 TV Road,
Pollok TX 75969

FCC Public File
publicfile@ktre.com
936-853-8639
EEO Report
Closed Captioning

All content © Copyright 2000 - 2014 Worldnow and KTRE. All Rights Reserved.
For more information on this site, please read our Privacy Policy and Terms of Service.