Ethics/Regulatory

CenterWatch Monthly March 2008 Issue

Monday, March 17, 2008 12:18 PM

Unanticipated Problems Reporting Adverse Events to IRBs

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Japan's New Regulatory Attitude Evident at DIA EuroMeeting

Wednesday, March 12, 2008 11:49 AM

One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who  was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.

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Ketek Hearing Winners and Losers

Wednesday, February 13, 2008 04:09 PM

After listening to the Feb. 12 hearing by the House Energy and Commerce’s Subcommittee on Oversight and Investigations probing study fraud and the antibiotic Ketek, one thing is clear: PPD, which monitored the study in question sponsored by Aventis (now Sanofi-Aventis), took the least hits from Congress. And it is also quite clear that many in Congress, including committee staff, don’t seem to understand much about the research process.

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CWWeekly January 22nd 2008 Issue

Friday, January 25, 2008 03:31 PM

Top News

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U.S. Supreme Court Will Not Hear Abigail Alliance v. Eschenbach

Monday, January 14, 2008 05:19 PM

The Abigail Alliance’s petition for a writ of certiorari in The Supreme Court of the United States was denied on January 14. A writ of certiorari is a document which a losing party files with the Supreme Court asking it to review the decision of a lower court.  It includes a list of the parties, a statement of the facts of the case, the legal questions presented for review, and arguments as to why the Court should grant the writ.

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AAHRPP Accredits Final Batch of Organizations for 2007

Thursday, December 20, 2007 01:21 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredited its final 11 organizations for the year.

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CWWeekly November 26th 2007 Issue

Friday, November 30, 2007 10:22 AM

Top News

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Nevada Doctor Reports Cherie Thibodeau to Attorney General’s Office

Monday, November 26, 2007 10:18 AM

Cherie Thibodeau, a fraudulent study broker, may not be working her scam much longer.

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Top Stories for the Week of Oct. 1st 2007

Friday, October 5, 2007 06:28 AM

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HHS Report Criticizes FDA’s Human Subject Protection Efforts and Lack of Site Audits

Friday, September 28, 2007 02:32 PM

The U.S. Food and Drug Administration (FDA) audited fewer than 1% of investigative sites, the inspector general of the Department of Health and Human Services (HHS), Daniel R. Levinson, found in a report released Friday.

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