Navigation Links
A brush with the U.S. Regulators can cost a fortune

The Food and Drug Administration held a meeting with Boston Scientific to talk about the repairs in the quality control problems.

A similar meeting was held in 2001 with Schering-Plough // about problems with its manufacture of asthma inhalers.

But the company failed to make any amendments. This provoked the FDA to withhold approval of Clarinex, a blockbuster allergy drug.

To solve this problem Raul E. Cesan, the company's president and chief operating officer with his executive team flew to Puerto Rico for a meeting with F.D.A. inspectors and officials.

The executives said that the meeting was very tense and Mr. Cesan was known for his autocratic style. One of the executives said that after a week there were FDA inspectors crawling in all the plants.

They found more problems and the approval of the drug Clarinex was delayed by more than a year.

The company also paid a fine of about $500 million. Mr. Cesan left the company in 2001 and has since founded an investment partnership. He is also a director of The New York Times Company.

In case of Boston Scientific if F.D.A. officials detect any defiance, the company could be in trouble.

Daniel E. Troy, a Washington lawyer who is a former F.D.A. general counsel said that in times of overall management failures the company has to show some efforts to repair the quality-control problems that were detailed in the agency's warning letter.

A lot depends upon how the company takes action and necessity changes.


'"/>




Page: 1

Related medicine news :

1. Cytobrush to detect oral cancer
2. Complaint about the levy of £1 a week for medical care alarm service, brushed of
3. Babys First Toothbrush Should Be a Cotton Swab
4. Cancer-causing Property Of Teflon Leaves US Regulators Concerned
5. Regulators Object Drug Produced from Genetically Engineered Farm Animals
6. Australian Drug Regulators Call for Revamp On The Pharmaceutical Surveillance
7. Drug Regulators Need To Think In Long-Term, Say Charities
8. European Regulators Investigate Common Painkiller Drugs
9. Canadian Regulators allow Silicone Breast Implants in Market
10. New Study Challenges How Regulators Determine Risk
11. Researchers Urge Regulators to Rethink Strategies for Soot Emission
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: brush with the Regulators can cost fortune

(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and ... Merchandise Show to bestow a Juvent Sports Achievement award ... Arlene McKitrick. The award commemorated and congratulated McKitrick for ... She won her first amateur tournament in 1979 and ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Autocarinsurancebest.com has released ... purchasing a commercial auto insurance policy . , Auto ... their vehicles. It is no longer necessary to call an ... are now available online on a single website: http://autocarinsurancebest.com/ ...
(Date:1/22/2015)... Joan Lunden, award-winning American journalist, beloved television host, ... 32nd Annual Miami Breast Cancer Conference planned and ... , shares that “a fast-growing, virulent” cancer in her ... not followed up her clean mammogram with an ultrasound. ...
(Date:1/22/2015)... 23, 2015 Recently, Weddingshe.com has added many ... has announced its highest annual revenues in the past three ... popular glamorous wedding dresses. , According to the sales manager ... dress promotions for them in 2015. This point can be ...
(Date:1/22/2015)... WASHINGTON, DC (PRWEB) January 22, 2015 ... conditions in vulnerable communities and cause financial distress to ... report by analysts at Howard University’s Center on Race ... of dollars in economic activity, payday loans at the ...
Breaking Medicine News(10 mins):Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2
... every resident in the city aged between 14 and 84 ... considered to be the most comprehensive in the history of ... ,Several thousands of free oral testing kits will ... person's HIV status within 20 minutes. The program uses the ...
... African American youth already prone to high-blood pressure ... if they are mentally stressed. // ,In ... natriuresis clusters with reduced endothelial function in African ... Kapuku and Harshfield tested ways to identify youth ...
... the Supreme Court had on Thursday announced in Mumbai a ... dental colleges across the state. , ,VJ Kulkarni ... after taking into account the total expenditure incurred by the ... increase and have written to committee chairman Justice A C ...
... World Cup with young men demanding "patriotic" hairstyles in ... only dare to try unusual hairstyles when mass enthusiasm ... the Cup," observes Stefanie Koehn, president of the German ... ,Demand for "really weird styles" of dyeing surged ...
... the most natural things in the world, a University ... increasing numbers// of Australian women want modern medicine to ... spinal blocks,amniocentesis, CVS testing. ,The University ... 21st century maternity care' - a conference organised by ...
... at the University of California, San Diego (UCSD) School ... cycles of liver cell// death and renewal – liver ... week of June 19 in advance of publication in ... underscores the importance of JNK1-mediated cell death and compensatory ...
Cached Medicine News:Health News:Mental Stress Linked To Higher Risk Of Heart Disease 2Health News:World Cup Fans go for Patriotic Hairstyles 2Health News:The Most Natural Thing in the World 2Health News:Repeated Liver Cell Proliferation, a Cause for Liver Cancer 2
(Date:1/23/2015)... 23, 2015  Mallinckrodt plc (NYSE: MNK ) ... a share repurchase program. The open-ended authorization permits the ... plc ordinary shares. "Funding additional initiatives ... as we continue to pursue a range of focused ...
(Date:1/23/2015)... , Jan. 23, 2015 Tianyin Pharmaceutical Inc. (NYSE ... specializes in the development and sale of patented biopharmaceutical ... active pharmaceutical ingredients (API) today announced the business and ... operation. 1. Following the September 2014 JCM ...
(Date:1/22/2015)... Jan. 22, 2015  Uroplasty, Inc. (NASDAQ: UPI ), ... innovative proprietary products to treat voiding dysfunctions, today reported ... 31, 2014.  Global revenue for the Company,s ... million, a new quarterly revenue record, as compared to ...
Breaking Medicine Technology:Mallinckrodt plc Announces Share Repurchase Program 2Mallinckrodt plc Announces Share Repurchase Program 3Mallinckrodt plc Announces Share Repurchase Program 4TPI's JCM Updates on Import Registration for International Clients 2TPI's JCM Updates on Import Registration for International Clients 3TPI's JCM Updates on Import Registration for International Clients 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 2Uroplasty Reports Record Revenue in Fiscal Third Quarter 3Uroplasty Reports Record Revenue in Fiscal Third Quarter 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 5Uroplasty Reports Record Revenue in Fiscal Third Quarter 6Uroplasty Reports Record Revenue in Fiscal Third Quarter 7Uroplasty Reports Record Revenue in Fiscal Third Quarter 8Uroplasty Reports Record Revenue in Fiscal Third Quarter 9Uroplasty Reports Record Revenue in Fiscal Third Quarter 10Uroplasty Reports Record Revenue in Fiscal Third Quarter 11Uroplasty Reports Record Revenue in Fiscal Third Quarter 12Uroplasty Reports Record Revenue in Fiscal Third Quarter 13Uroplasty Reports Record Revenue in Fiscal Third Quarter 14Uroplasty Reports Record Revenue in Fiscal Third Quarter 15Uroplasty Reports Record Revenue in Fiscal Third Quarter 16Uroplasty Reports Record Revenue in Fiscal Third Quarter 17Uroplasty Reports Record Revenue in Fiscal Third Quarter 18
... 15, 2011 A key component of health care ... when delivering health services, particularly for patients admitted to ... of California established the Center for Health Quality and ... across the UC health system. The center ...
... -- Mindray Medical International Limited (NYSE: MR ... devices worldwide, today announced updates on new product launches ... the first half of the year, the company successfully ... product lines. These include: a new anesthesia machine, a ...
Cached Medicine Technology:UCLA Receives Six UC Health Quality Grants to Improve Hospital Care 2UCLA Receives Six UC Health Quality Grants to Improve Hospital Care 3UCLA Receives Six UC Health Quality Grants to Improve Hospital Care 4UCLA Receives Six UC Health Quality Grants to Improve Hospital Care 5Mindray Medical Provides Mid-Year Update on Product Development 2
... The first-ever completely automatic ... that make it sophisticated yet ... a wide range of diagnostic ... without clinician intervention. This allows ...
The Guidant INSIGNIA Ultra pacing system offers sophisticated patient-specific, easy-to-use features for simplified patient management and enhanced patient safety....
The EUB-525 is a mid-size system with a full feature set. Capable of B-mode, M-mode, Doppler, Color Flow and Color Angiography it performs a variety of tasks in a simple and straightforward fashion....
... The EG-3630UR is a radial-type endoscope ... new technology gives a flicker-free, high-resolution image ... an optical system for direct visual observation. ... of performance as an endoscope as well ...
Medicine Products: