Christine P. Bump

Christine P. Bump

Principal, Penn Avenue Law & Policy
  • District of Columbia, Georgia
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Biography

Christine P. Bump is an insightful regulatory attorney with 20 years of experience developing and implementing FDA strategies for cutting-edge technology. She focuses on regulatory issues relating to devices, diagnostics, genetics and genomics, digital health, wellness, and advertising and promotion. Christine has been working on laboratory developed test (LDT) issues since 2004. She counsels laboratories, start-ups, and large corporations, and advises clients with an awareness and understanding of their business and strategic goals. Christine has prepared clinical trial and customer user agreements for laboratory and wellness products, with emphasis on patient and data privacy.

She has also developed regulatory strategies for new technologies related to IVF and pre-implantation selection, and served as dedicated counsel to a fertility clinic. Christine's 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.

Additional Practice Area
  • Food and Drug Law
Jurisdictions Admitted to Practice
District of Columbia
District of Columbia Bar
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Georgia
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Professional Experience
Vice President
Goldbug Strategies LLC
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Senior Associate
Goodwin Procter LLP
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Associate
Hyman, Phelps & McNamara, P.C.
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Education
Emory University School of Law
J.D. | Law
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Emory University
M.P.H | Health Policy and Management
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Sweet Briar College
B.A. | Government
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Honors: Honors Degree with High Honors; summa cum laude; Phi Beta Kappa
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Awards
Rising Star
SuperLawyers
Named a Rising Star in Food & Drug Law in Washington, DC
Dean's Public Service Award
Emory University School of Law
Phi Beta Kappa
Sweet Briar College
Presidential Medal
Sweet Briar College
Professional Associations
District of Columbia Bar
Member
- Current
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State Bar of Georgia
Member
- Current
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Food & Drug Law Institute
Member
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Women Owned Law
Member
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Food & Drug Law Institute
Editorial Advisory Board Member, Food and Drug Law Journal
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Food & Drug Law Institute
Member
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Food & Drug Law Institute
Editorial Advisory Board Member, Food and Drug Law Journal
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Publications
Articles & Publications
"Loper Bright Renews Interest in the VALID Act"
G2 Intelligence Lab Industry Advisor
"Webinar Recap: LDT Compliance Requirements for FDA Final Rule"
Today's Clinical Lab Thought Leadership Blog
"FDA's Final Rule on LDTs and What This Means for Laboratories"
Ideagen Blog
Quoted in "How to Keep Your Existing LDTs on the Market" by Jondavid Klipp
Laboratory Economics
Quoted in "How Much Will FDA Regs Cost Your Lab?" by Jondavid Klipp
Laboratory Economics
"The True Costs of FDA's Proposed LDT Rule and How Laboratories Can Prepare" (Co-Author)
Shadowbox Blog
"In Vitro Diagnostics Submissions and Compliance" (Co-Author), in Fundamentals of U.S. Regulatory Affairs, Sixth Edition
Regulatory Affairs Professional Society
"Environmental Health and Protection" (Co-Author), in Law And Public Health Practice, Second Edition Edition
Oxford University Press
"FDA Releases Final Guidance on ASRs"
Hyman, Phelps & McNamara Developments in the Law
"Questions Over FDA's Authority to Regulate Laboratory Developed Tests"
Hyman, Phelps & McNamara Developments in the Law
"Appeals Court Finds Right to Post-Phase I Investigational New Drugs: Makes Controversial Comments About Off-Label Use and Promotion"
Hyman, Phelps & McNamara Developments in the Law
"Clinical Trials Disclosure Requirements: Too Much of a Good Thing?" (Co-Author)
RA Focus
"Courts Scrutinize FDA 'Disgorgement' Demands"
Washington Legal Foundation Legal Backgrounder
"Qualified Health Claims: Creatures of Case Law"
FDLI Update
"New Case Raises Doubts on FDA's Autority to Obtain Restitution and Disgorgement"
FDLI Update
"Close But No Cigar: The WHO Framework Convenvention's Futile Ban on Tobacco Advertising"
Emory International Law Review
"Environmental Health and Protection" (Co-Author), in Law And Public Health Practice, First Edition
Oxford University Press
Speaking Engagements
"Loper Bright and the Potential Impact on the Laboratory Industry", Today's Clinical Lab Webinar, Virtual
G2 Intelligence
"FDA's Intent to Reclassify LDTs: What it Means and What Labs Need to Know", Next Generation Dx Summit, Washington, DC
Cambridge Analytics
"FDA's Final Rule on LDTs: What This Means for Laboratories", Ideagen Webinar, Virtual
Ideagen
"Dissecting FDA's Final Rule Governing LDTs & Effect on Laboratories", Diagnostics Coverage & Reimbursement Conference, Chicago, IL
Q1 Productions
"FDA's Final LDT Rule: Setting Priorities and Next Steps in Your Lab", Quadax, Inc. Webinar, Virtual
Quadax, Inc.
"Dissecting FDA's Proposed Rule Governing LDTs & Effect on Laboratories", Diagnostics Coverage & Reimbursement Conference, San Diego, CA
Q1 Productions
"What Post-Marketing Issues Should I Be Considering?", Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA, Virtual
Food & Drug Law Institute
"Dissecting FDA's Proposed Rule Governing LDTs & Effect on Laboratories", Quadax, Inc. Webinar, Virtual
Quadax, Inc.
"Dissecting FDA's Proposed Rule Governing LDTs & Effect on Laboratories", Diagnostics Coverage & Reimbursement Conference, Boston, MA
Q1 Productions
"Telemedicine and Remote Patient Monitoring: Public Health Emergency Next Steps & Associated Costs", Medical Device Coverage & Reimbursement Conference, Virtual
Q1 Productions
"Dissecting the VALID Act", Diagnostics Coverage & Reimbursement Conference, Chicago, IL
Q1 Productions
"Telemedicine and Remote Patient Monitoring: Public Health Emergency Next Steps & Associated Costs", Medical Device Coverage & Reimbursement Conference, Chicago, IL
Q1 Productions
"A Deep Dive Into Medical Device Regulatory Strategy", The FDA Group Podcast, Virtual
The FDA Group
"Dissecting the VALID Act", Diagnostics Coverage & Reimbursement Conference, Boston, MA
Q1 Productions
Moderator, “Preparing for the Next Public Health Crisis: Implementing a Culture-Centered Approach to Collaborative Communication Efforts by the FDA and CDC", The Interconnected Regulatory Landscape: Exploring FDA’s Relationship with Other Domestic Regulators, Virtual
Food and Drug Law Journal
"What Post-Marketing Issues Should I Be Considering?", Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA, Virtual
Food and Drug Law Institute
"Digital Health: Enforcement, Regulations, and Risks", FDLI Enforcement, Litigation, and Compliance Conference, Virtual
Food and Drug Law Institute
"Presenting Risk Information in Promotional Materials & Good Reprint Practices", Advertising and Promotion of Medical Devices in an Age of DTC and Social Media Marketing, Washington, DC
AdvaMed
"Premarket Notification, 510(k)", Introduction to Medical Device Law and Regulation, Washington, DC
Food & Drug Law Institute
"IVDMIAs: Is FDA Changing How Laboratories Operate?", Clinical Device Group E-Conference, Virtual
Clinical Device Group
"Legal and Industry Perspectives of FDA's Regulation of Medical Devices", Medical Electronics Conference, Minneapolis, MN
Surface Mount Technology Association
Websites & Blogs
Website
Penn Avenue Law & Policy
Social Media
Contact & Map
Penn Avenue Law & Policy
1455 Pennsylvania Avenue, NW
Suite 400
Washington, DC 20004
Telephone: (202) 489-0890
Monday: 9 AM - 6 PM
Tuesday: 9 AM - 6 PM
Wednesday: 9 AM - 6 PM
Thursday: 9 AM - 6 PM (Today)
Friday: 9 AM - 6 PM
Saturday: Closed
Sunday: Closed