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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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After the NDA is accepted the various section of the application should undergo concurrent...

2023-10-26T11:13:04

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Proposed instructions for use or electronic instructions for use and labels.] (b) Data to ...

2023-10-05T05:45:10

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2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationale fo...

2023-10-05T05:43:24

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Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succin...

2023-09-12T05:11:41

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PROVIDED that no fee shall be required to be paid by the institutes, organisation, hospit...

2023-08-04T04:51:07

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Ethics Committee This section shall document that the clinical investigation was conducted...

2023-07-12T05:21:00

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

2023-10-28T05:39:00

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