Ethics/Regulatory

C-TASC to Help FDA Improve NDA Review Process

Thursday, October 16, 2008

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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Conflict of Interest Case Could Change Disclosure Rules

Tuesday, October 14, 2008

The congressional investigation into an influential psychiatrist’s failure to disclose more than a million dollars in drugmaker payments is the latest in a spate of conflict-of-interest investigations that may force changes in the way financial disclosures are handled.

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Stay Granted in Muscular Dystrophy Clinical Trial Case

Friday, September 19, 2008

The U.S. Court of Appeals for the Third Circuit has granted PTC Therapeutics’ request for a stay of the Federal District Court’s decision on August 20 that would have forced the biotech company to provide its experimental drug PTC124 to 16-year-old Duchenne muscular dystrophy patient Jacob Gunvalson outside its clinical trial process.

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