Bioequivalence and Bioavailability Forum • Some more info

Some more info [GxP / QC / QA]

posted by Ohlbe – France, 2021-09-17 22:28 (1720 d 06:18 ago) – Posting: # 22587
Views: 21,510

Hi ElMaestro,

❝ One good question is what happens now. I would not be surprised if PanExcell and Synchron will cease to exist (might pop up under another name?), sponsors using the two CROs will be forced to abandon some/all of their MA's and/or repeat studies

Yes, indeed, in the USA: instructions to companies have now been posted on the FDA web site. Repeat all studies; therapeutic equivalence of already approved products is meanwhile changed to BX. Europe: it should not take them more than a year or two to decide what to do :sleeping:

❝ Have a look at the pdf files from FDA. Now answer this question: Which day were the letters issued?

❝ Do we really need to go looking for the date on the linking FDA page?

According to this new page: the letters were sent out on 15 September 2021.

—
Regards
Ohlbe

Complete thread:

Another two... Ohlbe 2021-09-16 23:41
- Another two... ElMaestro 2021-09-17 08:42
  - Dates Ohlbe 2021-09-17 10:15
  - Some more infoOhlbe 2021-09-17 20:28
    - EU Article 31 referral started Ohlbe 2022-01-24 17:47
- Cheating Helmut 2021-09-17 16:50
  - Increased variability Ohlbe 2021-09-17 17:56
    - Increased variability ElMaestro 2021-09-17 18:51
      - Visualization Helmut 2021-09-18 15:26
- Another two... jag009 2021-09-19 09:18
- Another two... ElMaestro 2022-05-24 12:00
  - Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
    - Blind monitors or greedy sponsors? Ohlbe 2022-05-24 14:21
      - Blind monitors or greedy sponsors? Helmut 2022-05-24 16:35
    - Blind monitors or greedy sponsors? ElMaestro 2022-05-25 08:11
      - (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
        
        Sponsors and CRO selection Ohlbe 2022-05-25 10:53
        
        I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
        
        T/R-ratios are useful Ohlbe 2022-05-25 14:40
        
        T/R-ratios are useful Helmut 2022-05-25 15:35
        Bust the Buster Helmut 2022-05-26 15:32
        
        complicate the assessor's life mittyri 2022-05-26 18:28
        
        complicate the assessor's life PharmCat 2022-05-27 09:57
        complicate the assessor's life Helmut 2022-05-27 10:11
        
        Thanks for Busting the Buster sameep 2022-05-31 08:34
        
        Thanks for Busting the Buster Helmut 2022-05-31 15:22
        
        A small point for the code sameep 2022-06-01 13:17
        
        A small point for the code Helmut 2022-06-01 14:11