WilmerHale Partner Bruce Manheim authored a chapter in the newly-released book, Inside the Minds: Food and Drug Litigation Strategies. Senior Associate Skye Perryman assisted in the development of this chapter.
"A Primer: Recent Developments and Strategies in Petitions and Lawsuits Challenging FDA Approval of Generic Drug Products Under the Administrative Procedure Act," addresses high-stakes litigation involving challenges to approval by the US Food and Drug Administration of generic versions of brand-name drug products. Many of the principles outlined in the chapter will also apply to challenges involving FDA review and approval of biosimilars.
Inside the Minds: Food and Drug Litigation Strategies provides an authoritative, insider's perspective on best practices for "leading lawyers on building strong defenses and adapting to evolving FDA regulations." It is available for purchase through Aspatore Books, a Thomson Reuters business.