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also known as Christine P. Bump, Christine Bump
Christine P. Bump is an insightful regulatory attorney with 20 years of experience developing and implementing FDA and related regulatory strategies for cutting-edge technology. She focuses on 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, academic medical centers, start-ups, and large corporations, and advises clients with an understanding of their business and strategic goals. Christine has prepared clinical trial and customer user agreements for laboratory and wellness products, with emphases 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 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.
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Practice Areas
21 years
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Chat withState: District of Columbia
Acquired: 2006
No misconduct found
State: Georgia
Acquired: 2004
No misconduct found
1455 Pennsylvania Ave NW Ste 400, Washington, DC, 20004-1017
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2013
Rising Star, SuperLawyers
2004
Dean's Public Service Award, Emory University School of Law
2000
Phi Beta Kappa, Sweet Briar College
2000
Presidential Medal, Sweet Briar College
2020 - Present
Principal, Penn Avenue Law & Policy
2015 - 2019
Vice President, Goldbug Strategies LLC
2009 - 2014
Senior Associate, Goodwin Procter
2004 - 2009
Associate, Hyman, Phelps & McNamara, P.C.
2021 - 2023
Food and Drug Law InstituteEditorial Advisory Board Member, Food and Drug Law Journal
2020 - 2024
Food and Drug Law InstituteMember
2020 - 2024
Women Owned LawMember
2010 - 2013
Food and Drug Law InstituteEditorial Advisory Board Member, Food and Drug Law Journal
2004
JD - Juris Doctor
2004
MPH - Master of Public Health
2000
BA - Bachelor of Arts
2025
Co-Presenter, "Untangling Uncertainty: What's Next in Clinical Lab Compliance?"
2025
Panelist, "Adapting to Payer Policy Shifts: Ensuring Compliance and Reimbursement"
2025
Panelist, "Where Are My Samples? Deconvoluting Biospecimen Supply Chain Logistics"
2025
"FDA Regulation of LDTs: The Impact on Clinical Trials for Precision Medicine"
2025
Beyond the LDT Ruling: Next Steps and What it Means for Your Lab
2025
"The Impact of PAMA, SALSA, and CLIA on Today's Diagnostic Landscape"
2025
Panelist, "FDA's Final Rule Vacated: What's Next for Your Lab?"
2025
FDA's LDT Rule: Are You Ready? (Co-Presenter)
2025
Co-Presenter, "AI Meets LDT: Navigating the New Frontier of Clinical Diagnostics"
2024
"Loper Bright and the Potential Impact on the Laboratory Industry"
2024
"FDA's Final LDT Rule: Settting Priorities and Next Steps in Your Lab"
2024
"Dissecting FDA's Proposed Rule Governing LDTs & Effect on Laboratories"
2024
Panelist, "Analyzing Specifications in the FDA Final Rule for Lab Developed Tests"
2024
"Dissecting FDA's Final Rule Governing LDTs & Effect on Laboratories"
2024
"Dissecting FDA's Proposed Rule Governing LDTs & Effect on Laboratories"
2024
"FDA's Intent to Reclassify IVDs: What it Means and What Labs Need to Know"
2024
"FDA's Final Rule on LDTs: What This Means for Laboratories"
2024
"FDA's Quality Management System Regulation: What Laboratories Need to Know"
2024
"What Post-Marketing Issues Should I Be Considering?"
2024
Panelist, "Impact of FDA Final Rule Regulating Lab Diagnostic Tests on Cancer Care"
2023
"A Deep Dive into Medical Device Regulatory Strategy"
2023
"Telemedicine and Remote Patient Monitoring: Public Health Emergency Expiration Next Steps & Associated Costs"
2023
"Dissecting FDA's Proposed Rule Governing LDTs & Effect on Laboratories"
2023
"Dissecting the VALID Act"
2022
Moderator, “Preparing for the Next Public Health Crisis: Implementing a Culture-Centered Approach to Collaborative Communication Efforts by the FDA and CDC"
2022
"Dissecting the VALID Act"
2021
"What Post-Marketing Issues Should I Be Considering?"
2020
"Digital Health: Enforcement, Regulations, and Risks"
2011
"Presenting Risk Information in Promotional Materials & Good Reprint Practices"
2010
"Premarket Notification, 510(k)"
2007
"Legal and Industry Perspectives of FDA's Regulation of Medical Devices"
2007
"IVDMIAs: Is FDA Changing How Laboratories Operate?"
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English