CDSCO enables online clinical trial site addition, investigator change

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CDSCO enables online clinical trial site addition, investigator change - Business Standard

Quick Summary:

The proposed addition or change will be deemed to be approved if no objection is raised by the CDSCO within a stipulated time frame.

The earlier notice had included only global clinical trials, clinical trials for new drugs, subsequent new drugs, investigational new drugs, fixed-dose combinations (FDCs), and bioavailability and bioequivalence studies.

Similarly, the CDSCO’s veterinary division had also switched the submission of Form 44 for the grant of permission to import or manufacture a new drug from offline to online mode.