ARTICLE | Regulation

Expanding acceleration

FDA, BIO converging on proposals to expand accelerated approval

January 23, 2012 8:00 AM UTC

FDA and the biotech industry are converging on expansion of accelerated approval beyond HIV and cancer as the best way to speed the development of therapies for serious unmet needs, but whether the agency proceeds on its own - and at its own pace - depends on whether both sides can agree on legislative approaches to include in PDUFA V.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, publicly unveiled her ideas about expanding accelerated approval in an interview broadcast Jan. 15 on BioCentury This Week television...