Bioequivalence and Bioavailability Forum • Assessment report published

Assessment report published [GxP / QC / QA]

posted by Ohlbe – France, 2024-06-05 14:45 (189 d 23:04 ago) – Posting: # 24022
Views: 3,823

Dear Helmut,

❝ Only one sponsor succeeded to get off the list. No idea how they did it.

The assessment report has now been published. Mystery solved. The MAH had submitted the same response as other MAH for the same product: Synapse only did a fed study, a fasting study was done elsewhere and is sufficient according to EMA's product-specific guideline. Due to a "technical issue" this response had not been considered during the initial assessment.

—
Regards
Ohlbe

Complete thread:

Another one? Helmut 2023-07-19 09:04 [GxP / QC / QA]
- Confirmed Ohlbe 2023-07-21 12:59
  - Who cares? Helmut 2023-07-21 14:24
    - Who cares? Ohlbe 2023-07-21 14:39
      - Expert Helmut 2023-07-21 14:41
  - Questions about data manipulation mittyri 2023-07-22 19:57
    - Data manipulation Ohlbe 2023-07-22 20:47
    - Questions about data manipulation wienui 2023-07-23 17:29
      - Questions about data manipulation qualityassurance 2024-04-30 11:38
        
        Questions about data manipulation Helmut 2024-04-30 11:46
        
        Questions about data manipulation qualityassurance 2024-04-30 13:55
        
        Questions about data manipulation Helmut 2024-04-30 14:52
        
        Assessment report publishedOhlbe 2024-06-05 12:45
        
        Questions about data manipulation Ohlbe 2024-04-30 18:25
        
        Questions about data manipulation ElMaestro 2024-05-01 07:10
        
        OT Helmut 2024-05-01 20:42
        Questions about data manipulation Ohlbe 2024-05-01 20:58
  - Update Helmut 2024-03-22 20:29
    - Health Canada recalls Helmut 2024-06-09 09:16
    - And the FDA… Helmut 2024-06-19 11:22
- Another one? Ajay Gupta 2023-07-24 04:19