FDA Approves Plan to Expand Experimental Drug Access to the Seriously Ill

The FDA approved a proposal to expand access to experimental drugs to seriously ill patients with no other treatment options. The proposal allows drug companies to give or sell experimental medicines to an even greater extent than had been previously allowed. While the expanded access was heralded by some, others worry that access to drugs outside of clinical trials will make it even more difficult to fill drug trials. In addition, this newly granted access may actually make it more difficult for drugs to gain FDA approval because reports of drug-induced death or sickness outside a monitored trial setting makes regulatory evaluation of a drug’s safety a little cloudier.

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