India tweaks presubmission rules on drugs, trials, devices and other regulated products

SINGAPORE--India's Central Drugs Standard Control Organization wants to tweak the rules on its presubmission process with agency staff and experts for approval of clinical trials, new drugs, medical devices and other regulated products. The new system is intended to help an applicant understand the appropriate requirements of the regulatory pathway and establish agreement between an applicant and the agency for specific filings, with a deadline for comments on Feb. 9. Notice (PDF)

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