chapter  21
18 Pages

CMC Postapproval Regulatory Affairs: Constantly Managing Change

WithLeo J. Lucisano, Kevin A. Miller, Lorien Armour

INTRODUCTION You arrive at work this morning feeling refreshed and unburdened. Last night was the first time in the last 6 months that you had a full and restful sleep. Late yesterday afternoon, you finally received the approval letter for the new drug application (NDA) for your company’s projected blockbuster product, and you are savoring the moment. You casually saunter to the break room for your morning cup of coffee, take a few minutes to celebrate with your coworkers, and return to your office, expecting a light day by recent standards. As you wait for your computer to boot up so you can catch up on the seemingly infinite backlog of e-mail, the phone rings. You note on the caller ID display that it is the marketing director for the new product. ‘‘She’s probably calling to congratulate me on the approval letter,’’ you speculate as you reach for the receiver. The tone of her greeting immediately tells you otherwise. New market research data just arrived on her desk that morning indicating that patients preferred a blister package compared to a plastic bottle. She wants to know if a submission is required for a blister package and, if so, how long it will take for preparation and approval. She indicates that time is of the essence to maximize market penetration, as a competitor’s product is anticipated to be approved imminently. While speaking with the marketing director, you receive an urgent message from your administrative assistant to call the vice president of manufacturing as soon as possible. You tell the marketing director that you will research the regulatory implications of the proposed packaging change and will call her back with an answer as soon as possible.