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

2023-10-13T05:19:56

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7.2.2 Review of requirements related to the product: The manufacturer shall review the req...

2023-10-13T05:13:58

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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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Note 2 : Provision of the medical device for purposes of clinical evaluations and/or evalu...

2023-10-13T05:22:38

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7.5.2 The manufacturer shall validate any processes for production and service provision w...

2023-10-19T07:17:46

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The manufacturer shall establish arrangements for these processes including, as applicable...

2023-10-17T05:36:04

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7.3.1 Design and development planning: The manufacturer shall establish documented procedu...

2023-10-13T05:16:35

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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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7.3.3 Design and development outputs: The outputs of design and development shall be provi...

2023-10-13T05:19:00

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