Expert: FDA Improvement in Predictability, Review Requests Is Behind Approval Spike

The FDA is realizing industry’s need for predictability and reasonable data requests during the review process, leading to the uptick in drug approvals seen so far this year, an expert says. This year, the FDA has approved 20 drugs and biologics — just one shy of its approval total for all of 2010, CDER Director Janet Woodcock told the House Energy and Commerce Subcommittee on Health last week.
Drug Industry Daily