Tag: phase I trial
Right-to-try is now law. Let patients beware!
Last week, President Trump signed the worst federal right-to-try bill under consideration by Congress into law. Its purpose was never to help terminally ill patients, and now that it's law there will be nothing the FDA can do to protect vulnerable terminally ill patients who choose it. That's a feature, not a bug. That's because right-to-try is the result of a collaboration...
Donald Trump versus the FDA: Is the standard of evidence for drug approval actually too low rather than too high?
All of the candidates being considered by President Trump for FDA Commissioner believe that the FDA is too strict in its standards for approving new drugs. In a commentary in Nature last week, two bioethicists argued that, at least in terms of preclinical data, the standard of evidence is actually too low. Which is correct?