Navigation Links
European Fine Chemicals Group Ratifies FDA's Proposed Generic Drug User Fees Act (GDUFA)
Date:9/9/2011

BRUSSELS, September 9, 2011 /PRNewswire/ --

The Board of the European Fine Chemicals Group (EFCG) is delighted to announce that today it agreed to ratify the proposal of the US Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and US industry representatives, to deliver into US law a new Generic Drug User Fees Act (GDUFA).

GDUFA requires the FDA to commit to significantly improve and enhance its regulatory activities for the benefit of global generic drug providers and US generic drug users, in exchange for the global generics industry providing FDA with $299 million in user fees each year over the next 5 years.

The key benefits for drug providers will be faster and more predictable regulatory review times, including dealing with the backlog of applications, and parity of inspections between domestic and foreign sites for both finished dosage form (FDF) and active pharmaceutical ingredient (API) manufacturers.

Guy Villax, CEO of Hovione and an EFCG Board member, who led the EFCG negotiating team, commented "the outcome of these negotiations are epoch-making for our industry and, if adopted, will go a long way to deliver on EFCG's major objective to level the playing field for its members. Regulators' weak enforcement has made non-compliance a major competitive advantage. We congratulate FDA for leading the way to find solutions that both protect the patient and stop unfair competition."

Notes for editors:

Generic drugs are those containing off-patent APIs made available to patients via a doctor's prescription. Over the counter (OTC) drugs available to patients without prescription are excluded from GDUFA.

For public minutes of industry meetings with the FDA see the FDA website at

http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm256662.htm

Th
'/>"/>

SOURCE Environmental Financial Consulting Group (EFCG)
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
2. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
3. European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day
4. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
5. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
6. Threshold Pharmaceuticals Announces Two Presentations on Glufosfamide at the 2007 European Cancer Conference (ECCO)
7. Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress
8. Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System
9. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
10. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
11. Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 2014  Australian drug delivery company, Phosphagenics Limited (ASX: ... A$19.3 million via a placement of A$16.3 million to ... U.S., Asia and ... purchase plan (SPP) to be offered to existing shareholders. ... two tranches. "This capital raising positions us ...
(Date:7/11/2014)... July 11, 2014  Veran Medical Technologies, ... today the positive, cost-effective final results for ... procedure. The SPiNPerc endobronchial percutaneous biopsy study ... approach to biopsy when a traditional bronchoscopic ... physicians experience positive financial outcomes when more ...
(Date:7/10/2014)... NEWS, Virginia , 11. Juli ... Hersteller von Kameras für die molekulare ... (MBI/BSGI), hat heute die CE-Zulassung für ... dem CE-Zeichen kann Dilon das Produkt ... Vertriebsbereich auf den Großteil der europäischen ...
Breaking Medicine Technology:Phosphagenics' A$19.3 million Capital Raising 2Phosphagenics' A$19.3 million Capital Raising 3Veran Medical Publishes Lung Cancer Patient Management Study 2Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2
(Date:7/12/2014)... July 12, 2014 As reported in ... of Standards and Technology), the June 25th, 2014 Supreme Court ... discovery world. It was also met with both ... on whether it was seen from an individual privacy perspective, ... is fact, there is now precedent which will require law ...
(Date:7/12/2014)... July 12, 2014 A recent article released ... a trio of suggestions for those seeking cosmetic surgical ... are rapidly approaching and the heat begins to enliven the ... their summer clothing, realizing that they didn’t work out as ... This can cause a sudden surge of people eager to ...
(Date:7/12/2014)... Seattle, Wa (PRWEB) July 12, 2014 ... by Doctors Sen and Samantha Pearson, a couple boasting ... chose to launch Restore My Vision Today as a ... that many ophthalmologists have become in their respective ... makes readers privy to a “secret” trove of pertinent ...
(Date:7/12/2014)... 2014 The largest pure occupational medicine ... to announce that it will be opening its fifth ... will join four Atlanta-based Nova Medical Centers’ locations. The ... Deans Bridge Road, and will be open from 8:30 ... “With Nova’s treatment philosophy of rapid return-to-work and decreased ...
(Date:7/11/2014)... DressyQuinceanera.com, a well-known wedding dress manufacturer and retailer, has ... online category. Furthermore, the firm has announced that all ... to 62% off. , The brand new Quinceanera Dama ... quality and style. All items in the new collection ... the company’s other items: lace evening dresses, short bridesmaid ...
Breaking Medicine News(10 mins):Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 2Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 3Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 4Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 5Health News:Best Summer Cosmetic Surgeries Revealed in Article By Seattle Plastic Surgeon 2Health News:Restore My Vision Today | Groundbreaking Book Reveals How To Restore Your Vision Without The Use of Glasses – Vinamy 2Health News:Restore My Vision Today | Groundbreaking Book Reveals How To Restore Your Vision Without The Use of Glasses – Vinamy 3Health News:Nova Medical Centers To Open New Facility in Augusta, Georgia 2Health News:DressyQuinceanera.com: Beautiful Quinceanera Dama Dresses At Low Prices 2
... (January 25, 2008) Research in the January issue ... (JACS) shows that many patients with minimal injuries ... and II trauma centers, despite the ability of the ... that overuse of trauma centers threatens to limit the ...
... Inc. (NYSE: WTW ) announced today that ... Sardini, Chief Financial,Officer, will present at the Credit ... The presentation will be held on Tuesday, ... a.m. local time) and will be accessible via ...
... to encourage Americans to ... 25 , Who: "The Biggest Loser" Season Four winner Bill Germanakos ... with MSN Health & Fitness and ... discuss "The Biggest Loser" Million Pound Match-Up sweepstakes, at ...
... Doctors Care is,pleased to announce the opening of its ... Hoffmeyer Road, Florence. The new center opened,January 23, 2008. ... scheduled to,open soon., Dr. Thomas Gibbons, the Midlands ... "Doctors Care is excited to provide convenient,urgent care, family ...
... 300-bed facility in Tempe, Arizona, raises MDS capacity in the ... Phoenix-area to 420 ... MDS Pharma,Services (http://www.mdsps.com ), a leading provider of innovative drug ... a new 300-bed Phase I facility in nearby Tempe, Arizona. The ...
... Md., Jan. 25 MiddleBrook,Pharmaceuticals, Inc. (Nasdaq: ... commercializing novel anti-infective products, today,announced that it has ... the private placement of 8,750,000 shares of,its common ... includes,five-year warrants to purchase 3,500,000 shares of common ...
Cached Medicine News:Health News:Excessive overtriage in US trauma centers overwhelming system resources, delaying patient care 2Health News:Weight Watchers to Present at Credit Suisse 10th Annual Global Services Conference 2Health News:Bill Germanakos and Hollie Self Bring 'The Biggest Loser' Million-Pound Tour, Presented by MSN, to Arizona Mills Mall 2Health News:UCI Medical Affiliates Inc. Opens New Doctors Care Center in Florence 2Health News:MDS Pharma Services Opens Largest Phase I Clinic on U.S. West Coast 2Health News:MiddleBrook Pharmaceuticals to Raise $21 Million Through Private Placement of Common Equity 2Health News:MiddleBrook Pharmaceuticals to Raise $21 Million Through Private Placement of Common Equity 3Health News:MiddleBrook Pharmaceuticals to Raise $21 Million Through Private Placement of Common Equity 4
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: