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Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii TGA ...

2023-08-25T05:22:17

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Phase I clinical trials Phase I clinical trials, also referred to sometimes as first-in-ma...

2023-03-29T05:59:19

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7.3.2 Design and development inputs: Inputs relating to product requirements shall be dete...

2023-10-13T05:18:32

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Details of suspected adverse device reaction(s): (a) Full description of reaction(s) inclu...

2023-07-12T04:40:52

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Design and development inputs: Inputs relating to product requirements shall be determined...

2023-07-05T05:22:42

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Procedural issues A system shall be established to enable cross-referencing of CRFs and CI...

2023-05-30T04:56:56

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Design and development inputs: Inputs relating to product requirements shall be determined...

2023-05-25T06:51:50

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Observational studies Observations on AEs, SAEs and benefits seen by the clinician or heal...

2023-04-18T06:01:59

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Guidelines for uploading data for Manufacturing and Formulation data / Written Confirmatio...

2023-04-25T05:58:45

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