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  2. Search results for "rationale"
Home / Search results for "rationale"

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

2023-10-28T05:47:16

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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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This summary may include: (a) Where a recognized standard exists, a declaration/certificat...

2023-10-03T05:13:09

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(f) animal studies that provide direct evidence of safety and performance of the device, e...

2023-09-16T04:41:25

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(f) animal studies that provide direct evidence of safety and performance of the device, e...

2023-09-14T05:12:50

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2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationale fo...

2023-10-05T05:43:24

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

2023-09-16T04:53:32

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

2023-09-16T04:51:42

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