The Development of Clinical Guidelines
One cannot really give an account of the development of “clinical guidelines” by drug regulatory agencies and others in recent years without first defining what one means by a guideline, since the term is used in several different senses. What these documents have in common is - or should be - that they serve only to guide, and that regulators, applicants and investigators must feel free to deviate from them where there is sufficient reason to do so.
KeywordsSufficient Reason European Economic Community CLiNICAL Requirement Drug Regulatory Agency Individual Recommendation
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