Industry To FDA: Generic Drug Review Delays Increase Healthcare Costs

Stakeholders urged FDA Monday (June 15) to address the increasing length of generic drug review times, with some saying the delays have cost the U.S. health care system more than $3 billion in the last year and a half alone and may cause companies to direct their manufacturing resources toward higher-priced drugs. They also pushed the agency to support a small business waiver in the next round of Generic Drug User Fee Amendments (GDUFA) negotiations. FDA kicked off the next...