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 jsa28@georgetown.edu 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


Students, Faculty/Staff, Alumni, Public






Mr. Dan Orr, Esq., Partner, Womble Bond Dickinson LLP

Open to the public and the press?


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Jeremy S. Alexander

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Jeremy S. Alexander

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