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:


(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... CA (PRWEB) , ... October 12, 2017 , ... ... Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent technology. ... a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can ...
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris F. ... AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking place ... the field of medical informatics, this prestigious award is presented to an individual whose ...
(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)... ... , ... Health Literacy Innovations (HLI), creator of the Health ... Cancer Patient Education Network (CPEN), an independent professional organization that shares best practices ... , As CPEN’s strategic partner, HLI will help support CPEN members by ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... 2017 Diplomat Pharmacy, Inc. (NYSE: ... Consulting, LLC , and named its founder as Diplomat,s ... Tennessee , will operate under Diplomat ... service offerings for health care partners to include IT ... "In an interoperable world, technology delivers comprehensive ...
(Date:10/2/2017)... Oct. 2, 2017 The Rebound mobile app is ... to reverse the tide of prescription drug addiction. The app ... medicine intake and stepping down their dosage in a safe, ... in December 2017; the first 100,000 people to sign up ... http://www.rebound-solution.com/ ...
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: ... data solutions, today announced that its MyDario product is expected to appear ... listings for when The Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, The ... ...
Breaking Medicine Technology: