3 ms·
A large percentage of companies don't do their post-market surveillance, and the FDA has never even once revoked approval because of it. The whole FDA approval
by Alex3917 11y ago
A large percentage of companies don't do their post-market surveillance, and the FDA has never even once revoked approval because of it. The whole FDA approval process is basically a scam.
- refurb 11y agoUhhh... that's not correct at all.[1] Are you confusing it with post-marketing commitments to run additional clinical trials? That's not the same thing as post-marketing surveillance. [1]http://www.fiercepharma.com/story/roche-overlooks-80000-adverse-reaction-complaints/2012-06-21 http://www.fiercepharma.com/story/roche-overlooks-80000-adve...
- Alex3917 11y ago"Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study." "Under the current system, the FDA has the authority to revoke approval of some drugs for which Phase IV commitments have not been honored. This authority has never been invoked." http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ http://www.citizen.org/hrg1520 http://www.citizen.org/hrg1520
- OopsCriticality 11y agoThe Phases apply to drugs, not devices.