In a cautiously worded essay, the Food and Drug Administration commissioner and more than a dozen other agency officials are trying to temper enthusiasm for a controversial provision in the 21st Century Cures Act, which was signed into law on Tuesday by President Obama.
The subject of their treatise is real-world evidence, a euphemism for various sorts of data that the law would allow the agency to use for approving additional uses of medicines, as well as for any follow-up studies that may be required. Such evidence could include electronic health records, observational studies, ongoing safety monitoring, claims data, and patient registries, among other things.
Skip this whole “efficacy” nonsense for drug approval, “safety” (doesn’t kill you within, let’s say, 3 weeks) is good enough! GREAT! again…
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