India consults on draft guideline for approving clinical trials and new drugs
This article was originally published in SRA
India's Central Drugs Standard Control Organization is seeking feedback on a draft guidance that describes its general requirements for approving clinical trials and various categories of new drugs1.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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