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- Hacker News
- At least clowns can be fun to watchby ubiquitysc
- “He had the temerity to reject a drug that had lousy data…”
Was that data really “lousy”? (Referencing the REPL data?) Was it a trial design issue? (which he has very strong and unconventional opinions on) Is it the role of his position to overrule his specialist review teams ? (in the absence of any clear safety risks or malfeasance)
by vibrio - My ex works in QA for a biotech company and FDA audits are a regular thing and are taken very seriously.
There's plenty to criticize of the org (as with almost all others) but the rank and file are doing good work to help try to keep us safe.
by pstuart - >In early August, soon after joining the FDA, Tidmarsh announced actions that would effectively remove from the market a drug ingredient made by a company associated with Tang. Tidmarsh’s lawyer then sent a letter to Tang proposing that he extend a “service agreement” for “another 10 years,” which would see Tang making payments to a Tidmarsh-associated entity until 2044. The email was seen as attempted extortion, with such payments being in exchange for Tidmarsh rolling back the FDA’s regulatory change.
Straight up extortion.
by duxup