US FDA Connects Dots For Drug Manufacturers’ Responses To CRLs With Draft Guidance
CRLs FDA submits in response to ANDAs increased most years since FY 2015, though FY 2020 total likely will be lower than two previous years. A 2019 CRL interrupted GSK's plans to market first mouth spray nicotine replacement therapy in US.
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No more than three votes decided the panel's recommendation on each FDA question, and members in the prevailing majorities explained they made their votes with reservations. Potential use by young consumers and confusion by adult users in following the label instructions were primary concerns for all panel members.