There are also [citizen’s] petitions for changing the labels on SSRI/SNRI meds and Accutane that have been in limbo for over a year now.
The FDA is nonchalant. It’s not them or their spouses or children. If they are pressed on the issue, they will cry that they are underfunded and understaffed.
It’s funny how they won’t even follow step with the MHRA or EMA now. So, what kind of blackmail material do you guys have in Europe to get your regulators to regulate?? j/k