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Bioethics and Research Protections News April and May 2009

Former Army Doctor Accused of Research Fraud Takes Leave From University. Duff Wilson and Barry Meier. The New York Times. 2009-05-22.
URL: http://www.nytimes.com/2009/05/23/business/23surgeon.html (Requires free registration.)

Senator Rebukes Medtronic Over List of Consultants. Barry Meier and Duff Wilson. The New York Times. 2009-05-20.
URL: http://www.nytimes.com/2009/05/21/business/21surgeon.html (Requires free registration.)

Medtronic INFUSE bone graft consultants: http://graphics8.nytimes.com/images/2009/05/20/business/GrassleyLetter.pdf

Doctor Falsified Study on Injured G.I.'s, Army Says. Duff Wilson and Barry Meier. The New York Times. 2009-05-12.
URL: http://www.nytimes.com/2009/05/13/business/13surgeon.html (Requires free registration.)

100cr scam in Tata cancer hospital. The Times of India. 2009-05-16.
URL: http://timesofindia.indiatimes.com/Cities/100cr-scam-in-Tata-cancer-hospital/articleshow/4537212.cms

Not the Garden State for Clinical Trials: NJ Takes on Device Manufacturer in Failure to Disclose Investigators' Financial Stake in Company. Christine P. Bump. FDA Law Blog. 2009-05-10.
URL: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/05/not-the-garden-state-for-clinical-trials-nj-takes-on-device-manufacturer-in-failure-to-disclose-inve.html

Looking back, years after Penn gene-therapy death. Marie McCullough. The Philadelphia Inquirer. 2009-05-08.
URL: http://www.philly.com/philly/news/homepage/44576977.html

Coast Institutional Review Board Press Release. 2009-04-29.
URL: http://www.coastirb.com/coastirb_fda

FDA Warning Letter to Coast Institutional Review Board (CDER, SUSP) 2009-04-14: http://www.circare.org/fdawls/coastirb_20090414.pdf

FDA Imposes Restrictions on Coast IRB due to Violations. FDA News Release. 2009-04-14: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149565.htm

FDA: Questions and Answers on Coast IRB April 14, 2009 Warning Letter. 2009-04-14: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ucm135468.htm

More information about Coast Institutional Review Board: http://www.circare.org/info/coastirb.htm

FDA clears Myxo ETlogix valve ring under new name but disagrees with earlier decision by Edwards that device did not need 510(k). Shelley Wood. HeartWire. 2009-04-14: http://finance.senate.gov/press/Gpress/2009/prg043009i.pdf

Another ex-Stryker Biotech rep. pleads guilty. Eric Convey. Boston Business Journal. 2009-04-14.
URL: http://boston.bizjournals.com/boston/stories/2009/04/13/daily25.html
Additional information and case documents: http://www.circare.org/lex/cases.htm#stryker

Hospital Gets Subpoena Tied to Doctor's Studies. David Armstrong and Keith Winstein. The Wall Street Journal. 2009-04-07.
URL: http://online.wsj.com/article/SB123905950162494901.html

Clinical Investigators and Criminal Liability: The Legal Landscape After U.S. v. Palazzo. FDA Law Blog. 2009-04-05.
URL: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/04/clinical-investigators-and-criminal-liability-the-legal-landscape-after-us-v-palazzo.html

Pfizer Reaches Settlement In Nigerian Drug-Trial Case. Joe Stephens. The Washington Post. 2009-04-04.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2009/04/03/AR2009040301877.html

Biotech's Baddies. Bob Grant. The Scientist. 2009;23(4):48.
URL: http://www.the-scientist.com/article/display/55525/ (Requires free registration.)


Last Updated: 2009-12-03

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