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APP Hires Reg Consultant for Review, CEO Departs

A.P. Pharma, Inc. has hired a consulting practice in regulatory affairs to lead the FDA Review Process for its lead product candidate, APF530 for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

A.P. Pharma, Inc. has hired a consulting practice in regulatory affairs to lead the FDA Review Process for its lead product candidate, APF530 for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting. APF530 is a long-acting formulation of granisetron that uses the company’s Biochronomer drug delivery system. In March 2010, the company received a Complete Response Letter from the FDA regarding its NDA, which outlined several issues to be addressed prior to FDA appro...

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