Chemistry, asked by priyabansal1158, 1 month ago

write in brief on documentation needed for new drug application

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Answered by XxSrishtiRajputxX

0

Answer:

The date regarding the trial protocol, investigator's brochures, and informed consent documents should also be attached. A copy of the application must be submitted to the ethical committee and the clinical trials are conducted only after approval of DCGI and ethical committee.

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