Events
Duane Morris Special Counsel Michael Swit to Present "The Gamechanger: Analyzing the Legal and Business Impact of the Generic Drug User Fee Amendments"
July 17, 2013 | The Carlton on Madison
| New York City
Duane Morris special counsel Michael Swit will discuss "The Gamechanger: Analyzing the Legal and Business Impact of the Generic Drug User Fee Amendments" at the American Conference Institute's (ACI) Legal & Regulatory Summit on Generic Drugs on Wednesday, July 17, 2013.
The Generic Drug User Fee Amendments of 2012 (GDUFA) requires the generic drug industry to pay user fees, estimated at $299 million for FY2013, to support the FDA's costs of reviewing generic drug applications and inspecting facilities. GDUFA has been touted as the means to reduce the FDA backlog, improve drug safety, and increase transparency. Questions remain as to what fallout should be expected as the industry assumes this new financial burden. "The Game Changer: Analyzing the Legal and Business Impact of the Generic Drug User Fee Amendments" will provide an in-depth examination of GDUFA, including its implementation and growing pains; the effects on smaller and foreign companies; its impact on the cost of business; and lessons learned.
Between the new requirements of the Generic Drug User Fee Act, the evolving risk of product liability exposure, and the barriers of REMS, the generic industry is facing formidable challenges on multiple fronts. To help make sense of these developments and their potential impact on the short and long terms goals of generic drug makers, the American Conference Institute has developed The Legal and Regulatory Summit on Generic Drugs as a "state of the union" of the legal and regulatory—as well as political and global—changes affecting the generic pharmaceutical industry. This exclusive forum for generic pharmaceutical companies brings together a distinguished faculty to address the intricacies and implications of these new developments as well as existing challenges affecting such core generic drug company functions as ANDA litigation, new product acquisition, intellectual property, regulatory affairs and policy positions.
To learn more and to register, please visit the ACI website. Use discount code 858L13.S to save $200 on registration.
