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3. Definitions In these rules, unless the context otherwise requires, — (a) "academic clin...

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Definitions In these rules, unless the context otherwise requires, — (a) "academic clinica...

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6. However, accelerated approval should be used for a drug that represent significant adva...

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

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Such discussion to help the reviewers becomes acquainted with the information to be includ...

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

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

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Recall Action Commencement Date: The date the recall strategy and communication was agreed...

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such as: (a) substances used for patient treatment (e.g. therapeutic drugs, anticoagulan...

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