In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word?
MaPP revision may be just a better description of ANDA evaluations – or indicative of a broad culture change, experts tell the Pink Sheet.
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FDA will be issuing discipline review letters and information request letters to generic drug applicants to communicate shortcomings in ANDAs. Under GDUFA II, the US agency agreed to send out these letters at the mid-point of the review clock.
Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.
Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.