flosz schreef op 16 mei 2015 12:20:
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Enjoy!
www.fda.gov/ForPatients/Approvals/Dru...www.fda.gov/Drugs/ResourcesForYou/Con...www.fda.gov/Drugs/ResourcesForYou/Con...www.fda.gov/downloads/AboutFDA/Report...www.cbg-meb.nl/CBG/nl/humane-geneesmi...How long does it take to complete each stage?
It can take up to 15 years to bring a product to market and then still require additional post-marketing Phase 4 studies:
Basic Research/Drug Development and Pre-Clinical/Translational Research (combined): 3 to 6 years
Phase 1, Phase 2, and Phase 3 Clinical Trials (combined): 6 to 7 years
FDA Review/Manufacturing: 0.5 to 2 years
Phase 4 Clinical Trial/Post-Market Surveillance/Report Adverse Events: 0.5 to 10 years (at least as long as the drug is on the market); Specific Phase 4 trials are optional and can be of variable length if assigned by the FDA as a requirement for a treatment’s approval. For example, some Phase 4 trials could last 5-10 years in order to see the effect of the treatment on populations of specific concern to the FDA. The post-market surveillance for adverse events begins immediately after the drug is available to the public and continues for at least as long as the drug is available on the market.
www.brightfocus.org/details-of-the-dr...