FDA

Is India Ready For Phase I Studies?

Tuesday, August 15, 2006 08:32 AM

India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer - and others would agree - is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies...

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The Right To Use Unproven Treatments?

Tuesday, August 8, 2006 03:11 PM

It’s ironic that at a time when several high-profile marketed drugs have been given a black box warning or withdrawn from the market that the Abigail Alliance has gathered steam.

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Super-Size The FDA

Friday, July 21, 2006 10:11 AM

A proposal in Congress to boost funding for the FDA makes a lot of sense. But don’t stop there, Congress - a super-sized FDA would help solve many of the issues around drug safety. Make sure it’s truly independent, though, and free from pressures from the pharmaceutical industry, brought upon it by a lack of resources. Drug research reformists often suggest creating an independent clinical trials agency to perform trials for the industry, but that’s a far-fetched and unworkable solution.

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Adapting To A New Kind Of Trial

Monday, July 17, 2006 11:29 AM

It’s great to see the FDA making a move this week to develop guidelines for adaptive clinical trials. Their time has come, given recent advances in scientific tools, such as toxicogenomic assays.

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A New Era Begins for India’s Clinical Research Market

Friday, July 7, 2006 11:16 AM

India’s participation in global clinical trials has nearly quintupled between 2001 and 2005, as investment in the country by large international and domestic pharmaceutical companies, small and medium-sized Western biotechs and the National Institutes of Health (NIH) has grown as well. The clinical research outsourcing market in India grew to $70.5 million last year and will continue to climb.

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ICON Steers Toward Integrated Oncology Service Model

Tuesday, June 27, 2006 03:48 PM

During DIA 2006, CenterWatch got the inside scoop on ICON's new The Oncology Solution service model during an interview with imaging CRO Beacon Bioscience’s David LaPoint, Vice President of Business Development. Beacon Biosciences was acquired by ICON Clinical in July 2004. According to LaPoint, the solution will allow ICON to bring together their full range of clinical service offerings, including imaging, central laboratory, IVRS and CRF data services.

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Who Owns the Rights to Human Tissue?

Thursday, June 15, 2006 10:09 AM

A recent Boston Globe article reported on a National Institute of Health (NIH) senior scientist selling human tissue to drug giant Pfizer, for Alzheimer’s disease research.

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