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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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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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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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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-14T04:54:40

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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-13T05:26:51

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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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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...

2023-10-26T11:09:31

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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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