Follow-On Biologics Alternative Bill Progresses; IP Issues Remain Sticking Point
Executive Summary
Members of Senate Health Committee are making progress on an alternate bill to provide a mechanism for the approval of follow-on biologics
You may also be interested in...
Generic Biologics May See Life After PDUFA; Senate Mark-Up Possible In May
Leadership of the Senate Health Committee remains committed to creating a pathway for follow-on biologics, despite the fact that language was not included in an omnibus FDA bill passed out of committee April 18
Generic Biologics May See Life After PDUFA; Senate Mark-Up Possible In May
Leadership of the Senate Health Committee remains committed to creating a pathway for follow-on biologics, despite the fact that language was not included in an omnibus FDA bill passed out of committee April 18
PDUFA Draft Bill Adds $70 Mil. For Rx Safety To User Fee Totals; Mark-Up Looms
A draft of the bill to reauthorize FDA's user fee program would add $70 million to the total fee negotiated by the agency and industry in order to pay for additional Rx safety oversight