New ANDA Review Pathways: Should You Be A Priority Or Expedited?
Executive Summary
Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.
You may also be interested in...
More ANDAs To Be Eligible For Priority Review, Gottlieb Says
US FDA Commissioner says agency has necessary resources to expand priority review pathway even as multiple review cycles for generic applications remain common.
ANDA Sponsors Get Wide-Open Facility Deadline For Priority Review
User fee legislation says facility information to qualify for priority review must arrive two months in advance of ANDA, conflicting with narrow 'window' in FDA's draft guidance.
Breakthrough-Style Program For ANDAs Added To House User Fee Bill
Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.