> Approving drugs based on wishful thinking isn't how the process is supposed to work…
This is not entirely correct. There is relatively recent FDA guidance addressing the balance of pre market and post market data collection.[1] I am aware the title of the guidance says devices, but note that the center for biologics evaluation and research (CBER) is on the guidance.
That being said, my opinion is that this decision by FDA is an abomination — the second extremely questionable approval on Woodcock’s watch — and never should have happened.
This is not entirely correct. There is relatively recent FDA guidance addressing the balance of pre market and post market data collection.[1] I am aware the title of the guidance says devices, but note that the center for biologics evaluation and research (CBER) is on the guidance.
That being said, my opinion is that this decision by FDA is an abomination — the second extremely questionable approval on Woodcock’s watch — and never should have happened.
[1] https://www.fda.gov/regulatory-information/search-fda-guidan...