• 0 Posts
  • 12 Comments
Joined 1 year ago
cake
Cake day: June 15th, 2023

help-circle
  • I work in pharma, regularly writing and filing things with the FDA (and other agencies), and this has been a topic of conversation at work. The good news for people is that the EMA is still a thing in the EU. So, at least the large pharma companies (like the one I work for), are likely to not really change much about their quality control/processes/etc. because we will still need to conform to the EMA guidelines which are typically in line with the current FDA (sometimes more strict, sometimes less so). The real quality concern would be smaller companies that only file for products in the US. They would only need to meet whatever new FDA guidelines come into effect (if they even do, changing stuff like GMP guidance is extremely complicated and time consuming) since the US is their only market.



  • There is a lot of collaboration between the different instance admins in this regard. The lemmy.world admins have a matrix room that is chock full of other instance admins where they share bots that they find to help do things like find similar posters and set up filters to block things like spammy urls. The nice thing about it all is that I am not an admin, but because it is a public room, anybody can sit in there and see the discussion in real time. Compare that to corporate social media like reddit or facebook where there is zero transparency.