Drug Approvals And Launches From A Legal Perspective

Launching a drug and receiving approvals—whether it’s in the U.S. or globally—is challenging to navigate. It’s a process that often takes years and a lot of back-and-forth communication with regulatory bodies. In this episode, Torrey Cope, partner, food, drug, and medical device practice, Sidley Austin LLP, discusses drug approvals and drug launches from a legal perspective, including 1) his work as an attorney; 2) tips for drug approvals from a legal perspective; 3) current regulatory challenges the industry is facing in the U.S.; 4) the shift away from a one-sized-fits all approach to marketing and global launches; 5) tips for companies navigating the regulatory landscape in the U.S.; 6) when to launch a drug in a country outside of the U.S.; and 7) drug pricing. Join Meg Rivers, managing editor, as she dives into this topic with Cope.