Trending Topics in Healthcare IP - Hot Topics in FDA Regulation of Drugs and Devices
Thursday, September 28, 2017, 4:00pm - 6:00pm, Leichtag 107 (Leichtag Biomedical Research Bldg), Health Sciences, UC San Diego. Directions. Register
UC San Diego Research Affairs –The Office of Innovation and Commercialization is partnering with Foley and Lardner LLP, a premier law firm in corporate and intellectual property matters, to bring Trending Topics in Healthcare IP Seminar series to UC San Diego and the Mesa.
Under the Trump Administration, the Food and Drug Administration (FDA) has undergone significant changes in leadership. Under Dr. Tom Price, the Secretary of Health and Human Services, and Dr. Scott Gottlieb, there will likely be a number of new initiatives that will impact clinical research and the development of small molecule pharmaceuticals, generic drugs, biotech drugs, biosimilars, and medical devices. An appreciation of these changes is necessary for successful product development and commercialization of products regulated by FDA. Understanding the implementation of new initiatives early on in product development mitigates unnecessary and costly surprises. This panel will provide a review and discussion of new and expected changes in FDA’s regulation of pharmaceuticals and devices, address hot topics in FDA law and regulation, and provide strategies for integrating regulatory considerations during product development.