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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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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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15.However, detailed guidance documents should be prepared providing the requirements and ...

2023-10-28T05:49:46

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After the NDA is accepted the various section of the application should undergo concurrent...

2023-10-26T11:13:04

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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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When evaluating a consulting firm, consider the factors mentioned earlier, such as their e...

2023-10-20T06:45:30

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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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(3) In case of imported diagnostic in vitro diagnostic medical devices, the report of eval...

2023-10-05T05:38:09

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