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

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

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

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The Drugs & Cosmetics Act, 1940 and rules 1945 have entrusted various responsibilities to ...

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Sugam builds a comprehensive database of the various permissions and licenses issued by S...

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

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

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

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

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