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Design and development review: At suitable stages, systematic reviews of design and develo...

2023-11-04T05:19:45

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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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POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be des...

2023-10-28T05:47:16

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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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Such discussion to help the reviewers becomes acquainted with the information to be includ...

2023-10-26T11:10:29

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INDUSTRY AND CDSCO COMMUNICATION 1. CDSCO needs to work collaboratively and cooperatively ...

2023-10-30T06:20:03

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PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process a...

2023-10-30T06:19:04

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3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer a...

2023-10-28T05:42:42

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ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs...

2023-10-26T11:12:10

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