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 at 12:00pm to 1:30pm


Leavey Center, Leavey Program Room, #1606

Audience

Students, Faculty/Staff, Alumni, Public

Website

https://otc.georgetown.edu/events

Cost

FREE

Presenter

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

Open to the public and the press?

Yes

Event Contact Name

Jeremy S. Alexander

Event Contact Email

jsa28@georgetown.edu

Accommodations Contact Name

Jeremy S. Alexander

Accommodations Contact Email

jsa28@georgetown.edu

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