Navigation Links
Mylan CEO Heather Bresch Testifies Before Congress in Support of Generic Drug User Fee Program and Urges Update of Federal Food, Drug and Cosmetic Act of 1938 to Create a Level Playing Field for Manufacturers
Date:2/9/2012

its oversight responsibilities over all players supplying the U.S. pharmaceutical market."

"Inspection parity will also benefit foreign facilities, as well as small and first-time entrants to the industry, which are currently disadvantaged by delays in gaining approval for new products – brand or generic – due to a lack of a recent inspection history, which is required before a new product can be approved."

"Mylan urges Congress to pass GDUFA, as unanimously ratified by industry, and update the FDCA. By taking these steps, we can further reduce government and taxpayer health care spending through more timely access to affordable generic medicine; ensure American competitiveness by addressing the unlevel playing field currently faced by U.S. manufacturers through inspection rates that are four times that of foreign competitors; and equip FDA with the authority it needs to carry out its mission of protecting the drug supply in today's highly globalized industry," Bresch's testimony concluded.

About Mylan

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.

[1] U.S. Government Accountability Office. Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publicati
'/>"/>

SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR(R)
2. Mylan Receives FDA Approval for Generic Version of Parkinsons Treatment Sinemet(R)
3. Mylan Schedules Third Quarter 2009 Financial Results Conference Call and Live Webcast
4. Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
5. Mylan Confirms First-to-File Patent Challenge Relating to Caduet(R)
6. Mylan Receives Approval for Generic Version of GoLytely(R)
7. Mylan Declares Quarterly Preferred Stock Dividend
8. Mylan Pre-Pays All Scheduled 2011 Term-Loan Borrowings
9. Mylan Confirms First-to-File Patent Challenge Relating to Vytorin(R) Cholesterol Medication
10. Mylans President of Europe, Middle East and Africa Elected President of European Generic Medicines Association
11. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2015)... 2015 /CNW/ - Covalon Technologies Ltd. (the "Company" or ... announced the issuance of an aggregate of 30,000 stock ... an aggregate of 120,500 stock options to employees and ... over three years and will be exercisable for a ... $1.40 per stock option. About Covalon ...
(Date:3/27/2015)... Telbec/ - Russell Williams , President of ... the 2015-2016 Quebec Budget, noting the fiscal discipline and ... industry. However, the association is concerned about the decline ... government,s intent to strive for a balanced budget this ... Quebec,s economic development is encouraging," said ...
(Date:3/27/2015)... March 27, 2015   Cypher Genomics, Inc., ... new data showing that, compared to a panel ... provided highly equivalent interpretations of whether certain genetic ... so in a fraction of the time. Cypher,s ... more comprehensive genetic analysis in non-invasive prenatal testing ...
Breaking Medicine Technology:Covalon Announces Issuance of Stock Options 2Quebec 2015-2016 Budget: Rx&D welcomes fiscal discipline and biopharma working group, but the decrease in government spending on medicines is questioned 2Quebec 2015-2016 Budget: Rx&D welcomes fiscal discipline and biopharma working group, but the decrease in government spending on medicines is questioned 3New Data at ACMG Shows Cypher's Software Can Automate Interpretation of Genetic Variants to Advance Non-invasive Prenatal Testing 2New Data at ACMG Shows Cypher's Software Can Automate Interpretation of Genetic Variants to Advance Non-invasive Prenatal Testing 3
(Date:3/28/2015)... "Necrorun" was featured on NewsWatch as part of its ... and coolest applications on the market for iOS, Android, ... technology expert, conducted the app review and shared with ... with knights, nature, and peasants. , The first ... Eurogamer. The popularity of these games grew over the ...
(Date:3/28/2015)... Emergency Medical Care (EMC), a New ... recently commemorated its three-year anniversary of being the only ... to 24-hour urgent care, Emergency Medical Care offers its ... time, Emergency Medical Care’s Urgent Care NYC ... eye injuries, ear infections, fevers, insect bites, burns, animal ...
(Date:3/28/2015)... March 28, 2015 One in three ... to research presented today at the American Orthopaedic Society ... study examined the long term success of surgery for ... examined survey data from 242 patients who underwent ACL ... P. Roe, MBBS, FRACS, from North Sydney Orthopaedic and ...
(Date:3/28/2015)... (PRWEB) March 28, 2015 Andrew Hawley of ... 1960's Who psychedelic concert posters. The Who and the Doors ... on August 2, 1968. According to Hawley, “The Who toured ... concert halls and college campuses. Perhaps the most famous Who ... Jim Morrison and the Doors on August 2, 1968 at ...
(Date:3/28/2015)... (PRWEB) March 28, 2015 Designers and ... new overlay entitled Scratches 5K from Pixel Film Studios. ... effects to any media inside Final Cut Pro X” ... Corporate saves time and is an effective tool for ... FCPX Overlay Scratches 5K's intuitive grunge overlays. Simply drag ...
Breaking Medicine News(10 mins):Health News:A Grim Endless Runner Game Was Featured on NewsWatch Television on January 30, 2015 2Health News:Emergency Medical Care Celebrates Three Years of 24/7 Walk-In Urgent Care Services 2Health News:Young Athletes at Greater Risk for Re-Injury after ACL Surgery 2Health News:Avid Collector from Vintage Rock Posters, Inc. Announces His Search For Original 1960's Who Psychedelic Concert Posters. 2Health News:Pixel Film Studios Unveiled Scratches 5k for Final Cut Pro X Editors 2
... Practitioners of clinical medicine are familiar with learning ... minimize learning-curve effects on clinical care. Because similar learning ... researchers at Duke University Medical Center studied the phenomenon ... trial. Their findings point to ways to improve the ...
... Researchers seeking to learn more about stroke by studying ... this week releasing new findings that they hope will aid ... cancer. The Japanese team is reporting in a ... that they are optimistic that inhibiting a protein found on ...
... of prostate cell that has been largely ignored by cancer ... new studies by Howard Hughes Medical Institute (HHMI) scientists and ... his colleagues at the University of California, Los Angeles (UCLA) ... tumors in the prostate gland. Their studies, which were unveiled ...
... would assume that body-checking -- intentionally slamming an opponent against ... hockey. But they would be wrong. Findings from a ... of young hockey players, show that 66 percent of overall ... posts, colliding with teammates or being hit by a puck. ...
... The recent discovery of more than a thousand genes ... up a new approach to understanding the function and ... made even more compelling with the finding that dozens ... commonly mutated gene in cancer), suggesting that this class ...
... history of male breast cancer perceive themselves to be at ... a family history of female breast cancer; however those with ... know about or seek genetic testing than those with a ... led by researchers at the University of Louisville,s James Graham ...
Cached Medicine News:Health News:Clinical trials can be improved by managing the learning curve 2Health News:Clinical trials can be improved by managing the learning curve 3Health News:Snake venom studies yield insights for development of therapies for heart disease and cancer 2Health News:Snake venom studies yield insights for development of therapies for heart disease and cancer 3Health News:Snake venom studies yield insights for development of therapies for heart disease and cancer 4Health News:A new ground zero for prostate cancer 2Health News:A new ground zero for prostate cancer 3Health News:Most youth hockey injuries caused by accidents, not checking, UB study shows 2Health News:'Linc-ing' a noncoding RNA to a central cellular pathway 2Health News:Male breast cancer in family leads to high perception of risk, low likelihood of genetic counseling 2Health News:Male breast cancer in family leads to high perception of risk, low likelihood of genetic counseling 3
... 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 ...
... 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 ...
Medicine Products: