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India consults on draft guideline for approving clinical trials and new drugs

This article was originally published in SRA

Executive Summary

India's Central Drugs Standard Control Organization is seeking feedback on a draft guidance that describes its general requirements for approving clinical trials and various categories of new drugs1. The document, which does not apply to biologicals and vaccines, also outlines a comprehensive submission format that is expected to help manufacturers prepare for electronic submissions, which the CDSCO says it might adopt "in the near future".

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