Setting the record straight on accelerated approval

As we ’ve discussed on thisblogbefore, the U.S. Food and Drug Administration ’s (FDA)accelerated approval program has served as a critical lifeline for patients with serious and life-threatening conditions. The program was originally established at the urging of patient advocates during the height of the HIV/AIDS epidemic, in which patients waited years for the FDA to review and approve new treatments. From its inception three decades ago, the pathway ’s purpose has always been to get medicines to patients most in need, especially those who lack any viable treatment options. Without accelerated approval, patients in need would have fewer or no treatment options.
Source: The Catalyst - Category: Pharmaceuticals Tags: FDA Rare Diseases Accelerated Approval Source Type: news