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Posted On: 06/06/2023 4:07:58 PM
Post# of 145881
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Pity the poor FDA. They are just so, so behind on their work -- and it's ALL THE PANDEMIC'S FAULT -- that they say they're going to need at least the rest of the year to catch up, if they're lucky.
Oh boo hoo. So this will be their excuse for doing Big Pharma's bidding and screwing the small companies.
https://endpts.com/cbers-peter-marks-shares-p...e-backlog/
Oh boo hoo. So this will be their excuse for doing Big Pharma's bidding and screwing the small companies.
Quote:
Marks noted there’s “an awful lot to catch up on” as the agency emerges from the pandemic, pointing out the push for RSV vaccines as well as vaccines for tropical illnesses. The agency also racked up a backlog of inspections amid the pandemic that grew into the thousands, though CDER director Patrizia Cavazzoni said back in June that regulators had caught up on domestic pre-approval inspections, according to a report from RAPS.
“There were casualties of going at warp speed,” Marks said Monday in a panel moderated by Politico’s Katherine Foley. “For us at FDA, we’re in the process of just going through the backlog.”
......“The real greatest challenge for me is trying to figure out how much of what we did during the pandemic we can continue to do within our resources, and we’re just resource constrained,” Marks said. “We have to triage right now and that’s one of the reasons why, for instance, in rare diseases we’re going to run a Warp Speed-like pilot for a select few diseases to see if that really makes a difference.”
https://endpts.com/cbers-peter-marks-shares-p...e-backlog/
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