FDA will strengthen expanded access program for non-approved treatments
FDA Commissioner Scott Gottlieb, MD, has signaled that the agency will strengthen its expanded access (EA) program to enable more patients to access investigational medical products and treatments for serious or life-threatening diseases. Gottlieb’s commitment to the EA program follows the Right to Try (RTT) law, which allows certain patients to access investigational drugs if they have no FDA-approved treatment options.
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