OTC I2I: Moving from the Lab to the Clinic: Early-Stage Interactions with the FDA
Dan Orr is a Partner in the Washington, DC office of Womble Bond Dickinson. He helps clients ranging from start-ups to Fortune 500 corporations obtain FDA approval for medical products and navigate the agency’s regulations. Dan was previously a Regulatory Counsel at the FDA where he solved regulatory problems in a portfolio of drugs and biologics with combined annual sales of over $37 billion.
Dan will discuss when and how sponsors of early-stage medical products should begin talking with FDA. The seminar will cover small business support available from the agency, special product designations (such as orphan and regenerative medicine designations), early-stage development meetings, data expectations, and related topics.
Lunch will be provided, space is limited.
Please RSVP by Monday, September 9, 2019
to Jeremy S. Alexander at email@example.com or 202.687.7424.
Interested faculty, staff, and clinicians, undergraduate and graduate students, and entrepreneurs should attend.
Wednesday, September 11, 2019 at 12:00pm to 1:30pm
Leavey Center, Leavey Program Room, #1606