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After the NDA is accepted the various section of the application should undergo concurrent...

2023-10-26T11:13:04

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10.As provided in the rules, surrogate marker should be considered as an interim data poin...

2023-10-28T05:49:20

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Requirement of clinical trials on Indian populations The requirement for clinical trials o...

2023-04-21T06:50:50

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15.However, detailed guidance documents should be prepared providing the requirements and ...

2023-10-28T05:49:46

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If the application is for conduct of clinical investigation as a part of multi-national cl...

2023-07-07T04:23:27

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Pivotal Clinical Investigation: (i) The pivotal clinical investigation is a definitive stu...

2023-05-29T05:03:38

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Technical Review Committee Background Interaction with the pharmaceutical industry leaders...

2023-04-22T06:07:01

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Waiver of clinical trials Provision of a waiver should be used only when alternative mecha...

2023-04-21T06:59:34

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Terms of reference 1. To formulate policy, guidelines and standard operating procedures (S...

2023-04-21T06:30:13

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