Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review
Executive Summary
Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.
You may also be interested in...
Generic Priority Review Expanded In Senate User Fee Bill
Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.
Generic Priority Review Expanded In Senate User Fee Bill
Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.
REMS Could Block ANDAs With 'Legitimate Business Justification' In Senate Bill
Sen. Leahy's reintroduced CREATES Act allows generic sponsors to sue innovators who fail to provide sufficient quantities of REMS covered products, but seems to give wide latitude to courts; bill reflects Congress' broader focus on generic drugs to address drug pricing issue.