REMS Abuse Website: All Sizzle, No Steak?
AAM President Davis contends he hasn't seen any evidence showing that reference listed drug access inquiries webpage has changed innovator behavior.
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The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.
But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.
US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.