FDA

Guest Commentary: Setting Up Successful Investigator Meetings in Eastern Europe

Tuesday, December 16, 2008 08:00 AM

According to the August issue of The Centerwatch Monthly, the number of investigators in Central and Eastern Europe who filed Form FDA 1572s last year was close to 3,000, which means investigator participation in global clinical trials conducted in the region was up 25% over the prior year’s. Sponsors and global project managers from Western countries are managing teams and investigators from this region, and it is important for them to understand the specifics of this process.

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Rural Population Key to China’s Clinical Research Market

Friday, November 21, 2008 11:37 AM

In his presentation at China Trials 2008 in Shanghai, “Conducting Global Post-Marketing Surveillance Studies in China—Opportunity and Practical Issues,” Mark Engel, president and chairman of Excel PharmaStudies, a large China-based contract research organization, identified two megatrends that will drive post-marketing surveillance studies to China: the rapid aging of its population and its increasingly insured rural population.

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DIA Opens Beijing Office

Wednesday, November 19, 2008 11:13 AM

The Drug Information Association (DIA) has expanded its worldwide operations by opening an office in Beijing, China. Headquartered in Horsham, Pa., DIA has regional offices in Switzerland, Japan, and now China.

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Preclinical CROs Expand Operations to Shanghai

Monday, October 27, 2008 09:36 AM

China has seen significant growth in the area of drug research and development in the past few years, and this growth will continue into the fourth quarter of 2008 with the opening of two new preclinical facilities in Shanghai.

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C-TASC to Help FDA Improve NDA Review Process

Thursday, October 16, 2008 12:00 PM

Clinical Trials & Surveys Corp (C-TASC), a clinical trials solutions company, will assist the U.S.Food and Drug Administration (FDA) Centers for Quality Assurance and Biostatistics to develop new methods and procedures for evaluating all New Drug Applications submitted for FDA approval. Under the $5.5 million base contract, C-TASC will use components of its StudyCTMS study management software application to customize a solution for the FDA that will standardize how clinical trial data for new therapies will be presented and reviewed. C-TASC statisticians will also work with FDA staff to perform some of the data preparations and analyses for these reviews. StudyCTMS is C-TASC’s proprietary web-based data management solution that enables clinical trials managers to easily develop and manage clinical studies and deliver the accumulated data and metadata in an easy-to-read and FDA-acceptable format.

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CenterWatch Monthly October 2008

Friday, October 3, 2008 02:44 PM

Trio of Companies in Strategic Outsourcing Partnerships with Lilly

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Trial Results: Oncology

Wednesday, October 1, 2008 07:55 AM

PharmaMar reported positive results from a phase III trial of Yondelis for the treatment of ovarian cancer. This randomized study enrolled 627 women with ovarian cancer who had relapsed after receiving standard first-line chemotherapy, across several international sites.

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Terrifying Budget Numbers

Friday, September 22, 2006 03:52 PM

For all that consumers expect from the U.S. Food and Drug Administration, it is completely irresponsible of the federal government to fund it with less than $2 billion a year. By comparison, that’s exactly the same dollars the federal government is spending each week on the war in Iraq.

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FDA Offers Guidance on Informed Consent Exemptions

Wednesday, September 13, 2006 04:50 PM

Helping to quell a storm of a controversy, the FDA has issued new guidelines describing the circumstances when informed consent can be waived for clinical trials in emergency or ambulatory settings. It's a big issue. Informed consent is a 'sacred cow' in today's clinical trial industry, and rightly so.

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Disapproving Look

Tuesday, September 5, 2006 09:54 AM

Well, it’s about time the FDA took a hard look at the compounding of drugs at some pharmacies. Until now, the FDA sort of looked the other way at pharmacists who custom-blended drugs from bulk ingredients. Particularly popular have been custom hormone replacement therapies or drugs that remove an ingredient that may be an allergen.

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