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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Don't Assume Your ANDA Will Be Designated, US FDA Tells Aspiring Competitive Generic Therapy Sponsors
Final guidance clarifies that all sponsors who want CGT designation, which can bring exclusivity upon approval, should request it.
In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.
Meeting opportunities codified in GDUFA II were adapted from the new drug user fee program experience but may not be well suited to the commodified generic drug industry built on volume and speed, industry representatives said at the recent FDLI annual meeting.