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Details of suspected adverse device reaction(s): (a) Full description of reaction(s) inclu...

2023-07-12T04:40:52

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Procedural issues A system shall be established to enable cross-referencing of CRFs and CI...

2023-05-30T04:56:56

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User Manual Page | 4 1.1 What is a Serious Adverse Event A Serious Adverse Event (SAE) is ...

2023-04-25T05:30:39

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

2023-07-07T04:21:36

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

2023-05-29T05:02:42

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Subjects (a) Inclusion criteria for subject selection. (b) Exclusion criteria for subject ...

2023-07-11T04:39:40

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