The “Food and Drug Administration Amendments Act of 2007” (“the 2007 Amendments” or “the Amendments”) (P.L. 110-85) went into effect on October 1, 2007. These Amendments represent the most comprehensive overhaul of food and drug law since 1997. The 2007 Amendments implement several major changes to the Federal Food, Drug, and Cosmetic Act (“FDCA”), including: (1) the reauthorization, increase, and addition of new user fees for prescription drug and device products for another five years; (2) the increase of the Food and Drug Administration’s (“FDA”) regulatory authority to monitor the safety of marketed drug products and medical devices; (3) the addition of incentives for development and oversight of pediatric drugs and devices; and (4) the strengthening of food safety requirements. These Amendments do not include provisions to permit FDA approval of generic or “follow-on” biologics, a contentious topic that continues to be debated by Congress.