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

2023-10-28T05:49:20

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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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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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ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs...

2023-10-26T11:12:10

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Sugam builds a comprehensive database of the various permissions and licenses issued by S...

2023-12-29T05:07:19

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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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5. Clear policy on regulatory requirements, system and procedures is critical for efficien...

2023-10-28T05:39:56

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Further CDSCO along with state regulators, is jointly responsible for grant of licenses of...

2023-12-29T05:06:50

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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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