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6. However, accelerated approval should be used for a drug that represent significant adva...

2023-10-28T05:47:30

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

2023-10-28T05:39:00

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

2023-10-26T05:36:08

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

2023-10-25T05:12:59

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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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POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additi...

2023-10-30T06:18:22

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

2023-10-25T05:12:05

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