FDA Boot Camp

Deborah’s session, “Predicting How Changes Under a New FDA Commissioner Will Impact the Life Sciences Community,” will address the uncertainties surrounding the future of the Food and Drug Administration precipitated by FDA Commissioner Dr. Gottlieb’s resignation earlier this year. Deborah will discuss how the focus of the agency may shift going forward, with attention to the policies and regulations that may be enacted under a new Commissioner and the potential impacts on the current regulatory policies of the pharmaceutical, biologics, and medical device industries.

The conference will provide attorneys and executives in the life sciences industry with a core working knowledge of essential FDA concepts and the regulatory aspects of the commercialization process for biopharmaceutical products and medical devices. This year, the conference will include special focus sessions on FDA’s digital health initiatives and opioid and other controlled substances classifications.