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A PSUR should be structured as follows:— (a) Title Page: The title page of PSUR shall capt...

2023-05-29T09:13:40

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5. Sanitation: Availability of written specifications and procedures for cleaning the manu...

2023-09-12T05:14:19

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Important information on the System for Australian Recall Actions The TGA publishes inform...

2023-08-25T05:21:36

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Abbreviated terms and definitions A list of abbreviated terms and definitions of specializ...

2023-07-12T05:25:54

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Studies: This section of PSUR shall capture the brief summary of clinically important emer...

2023-07-08T06:51:16

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Actions taken in reporting interval for safety reasons: This section of PSUR shall include...

2023-07-08T06:48:46

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Equipment: (i) brief description of major production and quality control laboratories equ...

2023-06-26T07:15:26

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

2023-10-26T11:13:04

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