FDA and You - DIA has you covered this fall (FDASIA, UFA and PDUFA)

The Food and Drug Administration Safety and Innovation Act (FDASIA) is Law. Now What? Join DIA, Food and Drug Administration (FDA), and The Food and Drug Law Institute (FDLI) as they convene the foremost experts in separate meetings to explain the nuances and forecast the implications of the User Fee Acts—PDUFA V, MDUFA III, GDUFA and BsUFA. DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA September 12-13 | Washington, DC Co-sponsored by In 2009, the Biologics Price Competition and Innovation Act (BPCI Act) was enacted as part of the Affordable Care Act. This conference will deal with the scientific and regulatory issues related to the demonstration of biosimilarity, focusing both on the FDA’s current thinking on approaches to biosimilar development as well as perspectives of other regulators. In collaboration with Keynote Speaker: Janet Woodcock, MD Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) View Program Details | Enroll Today Unwrapping FDA's 2012 UFA Package: What's Inside the Statute, What's Next? September 20 | Washington, DC Co-sponsored by The content of the UFA packages will shape the timeliness of reviews of life-saving medicines and medical devices, the requirements of all phases of medical product development, and the industry’s ability to innovate and develop needed medical products. This one-day conference will provide a first look at the final packages enacted for PDUFA V, MDUFA III, GDUFA and BsUFA. FDA will discuss the goals and commitments for their Centers, the changes of emphasis, and the potential impact on future programs. Reactor panels will provide the exchange of views on what the UFA provisions will mean for innovation, how they will improve patient access to needed medical products over the next five years, and next steps in preparing for 2017. Keynote Speakers: Jeanne Ireland Assistant Commissioner for Legislation Food and Drug Administration (FDA) Jeffrey E. Shuren, MD, JD Director, Center for Devices and Radiological Health (CDRH) Food and Drug Administration (FDA) View Program Details | Enroll Today DIA/FDA Industry PDUFA V Conference October 18-19 | Arlington, VA Co-sponsored by This two-day conference sets the stage for professionals in the FDA, Industry, patient, consumer, and health care groups to give new perspectives to current plans and potential impact on all stakeholders on the Prescription Drug User Fee Act (PDUFA). When PDUFA was enacted in 1992, it created amazing forward thinking in public health. Patients now have quicker access to over 1,500 new biologics and drugs, focusing on cancer treatments, infectious diseases, neurological and psychiatric disorders, and cardiovascular diseases all the while maintaining FDA’s meticulous safety and drug efficacy standards. With the recent authorization of PDUFA V, this conference will explore the next steps. View Program Details | Enroll Today