Scott D. Tomsky is Vice President, Regulatory Affairs, Generics, North America at Teva. He has been actively involved in the pharmaceutical industry for more than 20 years. Scott has held various positions in R&D, Quality Control and Regulatory Affairs at Johnson and Johnson, Ranbaxy and Teva. He was a member of the Industry negotiating team for the first reauthorization of the Generic Drug User Fee Program (GDUFA-II) and is currently a member of the industry implementation team for GDUFA-II. His experience includes filings and strategy for DMFs, ANDAs, and 505 b 2 NDAs, which spans many dosage forms including sterile products, solids, liquids, transdermals, inhalation products, and drug-device combination products in the US and Canada.