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

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Accredited Consultants area of expertise varies from Compliance Certification ( BIS, WPC, ...

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3. To enhance the communication aspects, CDSCO should ensure that the industry representat...

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PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process a...

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10.As provided in the rules, surrogate marker should be considered as an interim data poin...

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3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer a...

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

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

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BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmet...

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