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Home / Search results for "detailed information"

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

2023-10-30T06:21:42

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INDUSTRY AND CDSCO COMMUNICATION 1. CDSCO needs to work collaboratively and cooperatively ...

2023-10-30T06:20:03

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POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additi...

2023-10-30T06:18:22

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

2023-10-28T05:42:42

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

2023-10-28T05:40:49

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

2023-10-28T05:39:00

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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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