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Ted Cruz co-sponsors bill to expedite FDA approval for COVID19 drugs and devices
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Last: 6 yr ago by cisgenderedAggie
Probably going to be an unpopular opinion, but after reading yesterday I'm a little more worried this could end badly. Will have to learn more about what corner cutting is being proposed.
I don't want them to cut safety corners, but I do want them to temporarily set aside other work and concentrate their staff resources on getting COVID-19 medicine out to the public as fast as possible.cisgenderedAggie said:
Probably going to be an unpopular opinion, but after reading yesterday I'm a little more worried this could end badly. Will have to learn more about what corner cutting is being proposed.
If hospitals can postpone all non-critical treatments as necessary to free-up resources to deal with the virus, so can the FDA bureaucrats.........
I don't think that's really how the FDA works. They review what is brought to them and shuffle priorities as appropriate. Probably not best to reassign reviewers to areas outside their expertise.
I expect them to concentrate all the relevant resources on this problem. If that means, for example, having teams of reviewers on duty 24/7 with all the necessary staff and technical resources and approval authorities already pre-positioned at their fingertips, then do it. My point is that this is war, and I just want the FDA to act like it.
This is how every zombie movie gets started
I think they are doing that. See the Roche approval last week.
I know it's fun to beat up on the FDA, but reviewers sitting on their ass, even during non-emergency, isn't really consistent with my experience working with them. More often, it's a sponsor that doesn't have their **** together.
I know it's fun to beat up on the FDA, but reviewers sitting on their ass, even during non-emergency, isn't really consistent with my experience working with them. More often, it's a sponsor that doesn't have their **** together.
That was for a test kit correct? That doesn't require use of humanscisgenderedAggie said:
I think they are doing that. See the Roche approval last week.
I know it's fun to beat up on the FDA, but reviewers sitting on their ass, even during non-emergency, isn't really consistent with my experience working with them. More often, it's a sponsor that doesn't have their **** together.
I want something quick, but i want it to be safe. The doctor stickied at the top of this forum mentioned that it's first given to animals and after a period of time after deemed safe a trial on humans. That seems like that could take many months. I hope this part of the process is not rushed.
No, but it requires approval of effectiveness and the proposed legislation applies to both drug and device. Admittedly, the threshold of proof is quicker and easier to attain than for a drug, but a 12 hr turnaround for a diagnostic is pretty damn expedited.
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