House PDUFA Bill Would Cut FDA Response Time on Blocking Petitions for Biosimilars

The omnibus FDA user fee bill now before the House would limit to 150 days the amount of time the FDA has to respond to citizen petitions seeking to block biosimilars approvals. The House Energy and Commerce Committee Friday added that provision to the FDA Reform Act, H.R. 5651, which the House is set to take up this week.
Drug Industry Daily