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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

2023-10-17T05:26:07

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Design and development validation: Design and development validation shall be performed in...

2023-11-04T06:10:50

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

2023-10-28T05:47:30

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

2023-10-26T11:12:10

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

2023-10-25T05:12:59

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Note: Configuration management is a means by which identification and traceability can be...

2023-10-17T05:40:48

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Obtaining a regulatory license often involves an application process, fees, background che...

2023-10-21T04:47:14

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