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

The European Fine Chemicals Group was formed in 2004 as a sector group of the Brussels-based European Chemical Industry Council (Cefic) and represents fine chemical manufacturers in Europe, including those who make generic APIs. See http://www.efcg.cefic.org

 

For further information, contact Tony Scott, Adviser to EFCG on tscott@tsassoc.eu , +44-1428-641-168


 


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

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:9/28/2017)... Sept. 28, 2017 Hill-Rom Holdings, Inc. (NYSE: ... conference call and webcast on Friday, November 3, 2017, ... and ending at approximately 8:30 a.m. (CDT) / 9:30 ... company,s 2017 financial performance and guidance for 2018, Hill-Rom ... to enhance operational performance, and long-range financial outlook through ...
(Date:9/25/2017)...   Montrium , an industry leader in ... IQPC Trial Master Files & Inspection Readiness Conference ... Clinical Services has selected eTMF Connect ... EastHORN, a leading European contract research organization (CRO), ... to enable greater collaboration with sponsors, improve compliance ...
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical (AVACEN) ... is now successfully helping those with the widespread pain ... Fibromyalgia diagnosed Amanda in Essex, England ... washing my hair, experiencing no sleep at all, tremendous ... spasm… I cannot recommend [the AVACEN 100] enough, how ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... Coveros, a leader in agile coaching ... contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile ... of Agile methodologies in a consistent and high value manner across CMS programs. ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 ... characterized by frequent cessation in breathing. Oral appliances can offer significant relief to ...
(Date:10/12/2017)... ... , ... The American College of Medical Informatics (ACMI) will present the 2017 ... Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is ... pioneer in the field of medical informatics, this prestigious award is presented to an ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader ... a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were ... 11, 2017. , The annual award competition recognizes editorial and design excellence across a ...
(Date:10/12/2017)... ... October 12, 2017 , ... Health Literacy Innovations ... literacy software tool, and the Cancer Patient Education Network (CPEN), an independent professional ... announce a new strategic alliance. , As CPEN’s strategic partner, HLI will ...
Breaking Medicine News(10 mins):