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7.53.3 Status identification The manufacturer shall identify the product status with respe...

2023-10-17T05:41:39

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1.8 Domestic price of the device in the currency followed in the country of origin. 1.9 L...

2023-09-13T05:15:38

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Clinical investigation team Briefly describe the administrative structure of the clinical ...

2023-07-12T05:23:02

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CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the clinical...

2023-07-12T05:02:16

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INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed consent ...

2023-07-12T04:47:15

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Presentation of individual case histories: This section of PSUR shall include the individu...

2023-07-08T06:50:30

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Status identification The manufacturer shall identify the product status with respect to m...

2023-07-06T04:53:39

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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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