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

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

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(iii) a table compiling all observed device deficiencies that could have led to a serious ...

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Investigational medical device and methods 6.1 Investigational medical device description ...

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General Central Drugs Standard Control Organization, Ministry of Health and Family Welfare...

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Pilot Clinical Investigation: (i) Pilot clinical investigation is defined as those clinica...

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Introduction The introduction may contain a brief statement placing the clinical investig...

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