Clinical Research Regulation: FDA vs. ICH

On May 9th, 1997, the US Food and Drug Administration (FDA) published in the FEDERAL REGISTER (vol. 62, No 90), the latest rendition of the International Conference on Harmonization (ICH) Guideline covering the conduct of clinical research studies in the seven member nations. Guidelines represent the agency's current thinking on Good Clinical Practices, but do not bind the FDA or the public. However, most clinical research studies are now being conducted in compliance with this guideline, especially if the results might be used for an international regulatory submission. Here are the major differences.

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Saving a Struggling Safety Study

Selecting a contract research organization (CRO) from among the 1,000 or so competitors is a challenging task for any sponsoring pharmaceutical or medical device company. But, it is particularly difficult for an inexperienced team at a startup just entering Phase 1 human trials with their first new product. Such young companies are often working under extreme deadlines imposed by shortsighted venture capitalists clamoring for a press release announcing the start of clinical testing to buoy the stock price.

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