FDA

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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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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