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Best Regulatory Affair in Delhi NCR. iv Recall Action Level: The level to which the recall...

2023-10-20T06:36:36

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The parameters for classification of in vitro diagnostic medical devices as follows:— (i)...

2023-06-22T06:19:48

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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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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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(b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall ...

2023-09-02T09:21:47

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If the medical device is intended to treat serious or lifethreatening diseases, occurring...

2023-07-07T04:35:43

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Responsibilities of the Ethics Committee: (i) It is the responsibility of the Ethics Commi...

2023-07-07T04:17:20

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Paediatrics: (a) The timing of pediatric studies in the medical device development program...

2023-05-29T05:09:16

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