Bioequivalence and Bioavailability Forum • Another two...

Another two... [GxP / QC / QA]

posted by ElMaestro – Denmark, 2021-09-17 10:42 (1124 d 20:39 ago) – Posting: # 22576
Views: 7,991

Yikes Ohlbe,

❝ It looks like the FDA has just keelhauled 2 CROs again: Panexcell and Synchron Research. The FDA will reject all data from both CROs due to data manipulation. All Panexcell data had already been rejected in the EU.

❝

❝ The FDA letters are very explicit regarding what they have found, and their conclusion is crystal clear:

❝

❝ Put simply, because you have been responsible for the creation of false data in the studies discussed here, we have no reason to believe that any data that you have produced are reliable. Thus, FDA has determined that all study data from all studies conducted at your firm must be rejected.

thanks for posting the info. These stories justify the existence of the SatoWIB and Buster software that's used to detect exactly the type of manipulation that FDA are worried about. FDA sends a remarkably clear message there.

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 even for EU and WHO, and regulators will more seriously start to consider how statistical (or pharmacokinetic) software screening for indicators of manipulation in their own right should be used routinely within agencies. There may be a little wars going on between assessors and inspectors all the while. E.g. whose job is it to screen and who takes decisions on the basis of the outcome? But Rome wasn't built in a day :-D

Bonus question:

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

Not written in the file? Well, then how about the meta-info embedded in the pd file? Oh, a date is not there either? Well, then... Do we really need to go looking for the date on the linking FDA page?
It is funny how, in this day and age when ALCOA and so forth is so fashionable, letters like these are not explicitly dated. Is there a reason?

Edit: 2 successive posts merged [Ohlbe]

—
Pass or fail!
ElMaestro

Complete thread:

Another two... Ohlbe 2021-09-16 23:41 [GxP / QC / QA]
- Another two...ElMaestro 2021-09-17 08:42
  - Dates Ohlbe 2021-09-17 10:15
  - Some more info Ohlbe 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