FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation | Politics
• The FDA has introduced a new fast-track program for the approval of biologics, including experimental gene therapies for conditions like sickle cell disease and cancer. • Traditionally, the agency requires a rigorous three-phase trial process involving healthy volunteers, dose-finding studies, and large-scale clinical trials to ensure safety. • Critics argue that these political shortcuts may undermine the FDA's international reputation and its standing as a global authority on drug safety.
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