Innovative developments in unapproved medical therapies are paving the way for the new frontier and the future of medicine. One patient in particular, Judi Polak, a former medical professional herself, is an example who puts into question the endpoints required by the gold standard Food and Drug Administration (FDA) drug approval process.
FDA determines the standards of two categories for drug approval: safety and efficacy. All new drugs coming to market must be put under rigorous testing to meet FDA standards, yet these standards vary from drug to drug, and therefore, there are often no objective standards that apply to the drug approval process. One might ask how we would know if a drug ought to be approved or not if the standards by which they are measured constantly vary?
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