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.
You may also be interested in...
Draft guidance says US FDA will try to expedite assessment of competitive generic therapy designees, but will not give shorter review goals.
Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.
Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.