Christine P. Bump

Principal | Experienced Regulatory Attorney

Introduction

Christine P. Bump is an insightful regulatory attorney with 15 years’ experience developing and implementing FDA strategies for cutting-edge medicine and technology. She advises CEOs, scientists, and teams of all levels on issues relating to devices, diagnostics, genetics and genomics, digital health, wellness, and advertising and promotion. Christine also counsels venture capital groups and portfolio companies on navigating the FDA process.

Christine works with a broad array of clients, from start-ups to large corporations, and is particularly astute at helping clients mitigate risks when their products are not clearly subject to FDA regulation. She develops regulatory strategies that comply with FDA regulation and guidance and meet the client’s business and development goals. Christine has developed regulatory strategies for drug/device combination products and pharmacogenomics, genetic and genomic tests, nutrigenetic and nutrigenomic tests, and digital health platforms.

Christine advises clients on clinical investigations, premarket submissions, pre- and postmarket compliance, and promotional issues. She prepares clinical trial and customer user agreements for laboratory and wellness products, with emphases on patient and data privacy. Christine has also developed regulatory strategies for new technologies related to IVF and pre-implantation selection, and served as dedicated counsel to a fertility clinic.

Her policy experience includes serving as a regulatory counsel for a national coalition of diagnostic companies. She has prepared unified comments on behalf of a coalition to FDA and Congress, and prepared lobbyists for meetings on Capitol Hill regarding alternatives to existing and proposed regulations. Christine has also analyzed state laws relating to genetic testing, direct access testing, pharmacy restrictions, and health care practitioners’ scope of practice, and has prepared white papers and Citizens’ Petitions to FDA on behalf of clients.

Outside of her legal practice, Christine is currently serving on the Editorial Board of the Food and Drug Law Journal. She also serves as a state scholarship chair for P.E.O., a philanthropic educational organization. For fun, Christine has renewed her childhood passions of singing and tap dance.

Experience

Before opening Penn Avenue Law & Policy, Christine served as Vice President of Goldbug Strategies LLC. Christine also worked as an attorney in the FDA practice group of Goodwin Procter LLP, and at Hyman, Phelps, & McNamara, P.C. Prior to her professional career, Christine served as both a Law Clerk and a Policy Fellow at the CDC and as an intern in the Clerk’s Office at the U.S. Supreme Court.

Education

J.D., Emory University School of Law
M.P.H., Emory University Rollins School of Public Health
B.A., Sweet Briar College, summa cum laude, with High Honors

Bar Admissions

District of Columbia
Georgia

Professional Affiliations

Food and Drug Law Institute
American Bar Association
Women Owned Law

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