Damn! you are right my friend, it's a clear possibility
I wasn't aware of that! I was believing that elimination of phase 3 would be ONLY for rare and serious diseases but I was wrong! thank you dude you made my day
its also said here :
http://www.collective-evolution.com/...eard-about-it/
"The 21st Century Cures Act allows drugs to be rushed to the market, removes phase 3 testing as a requirement for drug approval, bases drug approval on biomarkers rather than actual health outcomes"
And here:
http://www.raps.org/Regulatory-Focus...ury-Cures-Act/
Subtitle B of Title II is slightly modified from the original draft of the legislation. It remains focused on the "qualification and use of drug development Tools
"The development of biomarkers and other drug development tools can benefit the availability of new medical therapies by helping translate scientific discoveries into clinical applications," the bill explains
Section 2022 of the draft legislation would amend federal law to facilitate accelerated approvals—approvals based on surrogate (e.g. intermediate) endpoints intended to serve as evidence that a drug would be effective in a population.
FDA has long relied on surrogate endpoints to support accelerated approvals, but only for drugs intended to treat patients with life-threatening illnesses and unmet needs.The legislation would require FDA and a sponsor to enter into an "accelerated approval development plan" (AADP) similar in concept to a special protocol assessment (SPA). The AADP would establish the minimum data parameters which, if met, would support the approval of a drug using surrogate endpoints.
And from your link:
"This part of the bill allows drugs to get to the consumer quicker. This is because Phase 3 testing has been eliminated
The new method replacing Phase 3 testing bases drug approvals on biomarkers, the way living cells react to specific things introduced to those cells
The real world effects of this Act are still unknown but the central point of contention is singularly rooted in the
increased freedom and lack of oversight of pharmaceutical companies."
Sounds too good to be true x)
Im not aware of us, when do this bill will defenitly be adopted? Is there obstacles to come or can we say that it's just a matter of time?
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