FDA accepting 'breakthrough' applications

The "breakthrough" therapies pathway created by the FDA Safety and Innovation Act is "open for business," Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told BioCentury on Thursday. The agency has received "a lot of inquiries and more than one application" for products to be designated as breakthroughs, she said.

Products with the designation will receive "all hands on deck" treatment from the agency to expedite development, Woodcock said. The law requires that senior agency officials participate in a "collaborative, cross-disciplinary review" of breakthrough products, and that the agency ensure that trials required for approval are designed to be "as efficient as practicable." Under the law, FDA has 60 days to respond to an application for the designation (see BioCentury, July 2). ...