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CWWeekly March 27th 2008 Issue

Friday, May 30, 2008 03:11 PM

Top News

NIH Program to Study Patients with Mystery Diseases

For thousands of frustrated patients with diseases that cannot be explained or diagnosed—even by leading specialists in their field—enrollment in clinical trials has not been an option. Without a definitive diagnosis, they are ineligible to participate. Now, through a pioneering program launched by the National Institutes of Health (NIH), there may be hope. The new trans-NIH initiative, called the Undiagnosed Disease Program, will concentrate its research efforts on patients who suffer from unknown, thus unstudied, illnesses.

CDER’s Woodcock Details Expanded Authority, Sentinel Concept at Post-Approval Summit

Opening the Post-Approval Summit at Harvard, keynote speaker Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.

Other breaking news...

Pharm-Olam opens new office in Russia...
ClinPhone establishes new office in Paris...

Company Profile: An interview with Steve Toon, Ph.D., executive director, Simcyp

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December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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