New ANDA Review Pathways: Should You Be A Priority Or Expedited?
Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.
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US FDA Commissioner says agency has necessary resources to expand priority review pathway even as multiple review cycles for generic applications remain common.
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to qualify for priority review must arrive two months in advance of ANDA, conflicting with narrow 'window' in FDA's draft guidance.
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.