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January 22, 2024
Nashville partner Bob Wade will participate in the Health Care Compliance Association (HCCA) Anchorage Regional Compliance & Ethics Conference in Feb. 22-23. The conference will include topics on regulatory requirements, compliance enforcement, risk management, and maintaining an effective compliance program. Attendees will have the opportunity to earn live Compliance Certification Board (CCB) continuing education units (CEUs) and network with other professionals.
Anchorage Regional Compliance & Ethics Conference
Idea Exchange
Christopher Hanson
Partner
2 W. Washington Street
Suite 400
Greenville, SC 29601
Suite 900
Washington, D.C., 20001
Christopher is the chair of the firm’s FDA Regulatory Compliance & Litigation practice group. He assists clients in tackling their most sophisticated and high-stakes regulatory issues across a range of product categories, including medical devices, human and animal drugs, in vitro diagnostics (IVDs), conventional foods, dietary supplements, cosmetics, radiation-emitting electronic products, and clinical laboratories. He...
Christopher is the chair of the firm’s FDA Regulatory Compliance & Litigation practice group. He assists clients in tackling their most sophisticated and high-stakes regulatory issues across a range of product categories, including medical devices, human and animal drugs, in vitro diagnostics (IVDs), conventional foods, dietary supplements, cosmetics, radiation-emitting electronic products, and clinical laboratories. He aids clients in consequential interactions with the U.S. Food and Drug Administration (FDA) as well as other federal, state, and foreign regulatory agencies, such as the Centers for Medicare & Medicaid Services (CMS), the Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC), and the U.S. Department of Agriculture (USDA).
In his advisory practice, Christopher crafts creative and practical solutions for clients. His work also includes drafting FDA regulatory submissions as well as preparing public comments for agency rulemakings, guidance documents, advisory committees, and public policy venues. He provides strategic advice and regulatory due diligence to support corporate transactions and securities filings in the life sciences space. He also has experience counseling in FDA enforcement matters and conducting global internal investigations and audits of biotechnology, pharmaceutical, and medical device companies.
A prolific writer and frequent public speaker, Christopher is the author of “Overview of the Legal Framework for Medical Device Regulation in the United States” in PLI's Medical Devices Law and Regulation Answer Book (2023, 2021, 2019). He serves as the Vice Chair of the Executive Committee of SCBIO, South Carolina’s not-for-profit, public/private life sciences industry association. Christopher is a member of the 2023 class of Leadership South Carolina and serves as the President of the Piedmont Yale Club. In 2023, Governor Henry McMaster appointed Christopher to the Board of Trustees of the Children’s Trust of South Carolina, which is the statewide organization focused on the prevention of child abuse and neglect.
aids clients in consequential interactions with the U.S. Food and Drug Administration (FDA) as well as other federal, state, and foreign regulatory agencies, such as the Centers for Medicare & Medicaid Services (CMS), the Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC), and the U.S. Department of Agriculture (USDA).
In his advisory practice, Christopher crafts creative and practical solutions for clients. His work also includes drafting FDA regulatory submissions as well as preparing public comments for agency rulemakings, guidance documents, advisory committees, and public policy venues. He provides strategic advice and regulatory due diligence to support corporate transactions and securities filings in the life sciences space. He also has experience counseling in FDA enforcement matters and conducting global internal investigations and audits of biotechnology, pharmaceutical, and medical device companies.
A prolific writer and frequent public speaker, Christopher is the author of “Overview of the Legal Framework for Medical Device Regulation in the United States” in PLI's Medical Devices Law and Regulation Answer Book (2023, 2021, 2019). He serves as the Vice Chair of the Executive Committee of SCBIO, South Carolina’s not-for-profit, public/private life sciences industry association. Christopher is a member of the 2023 class of Leadership South Carolina and serves as the President of the Piedmont Yale Club. In 2023, Governor Henry McMaster appointed Christopher to the Board of Trustees of the Children’s Trust of South Carolina, which is the statewide organization focused on the prevention of child abuse and neglect.
Experience
Representative Matters
Human and Animal Drugs and Medical Devices (Including Diagnostics)
- Supported medical device manufacturers in regulatory strategy and drafting Emergency Use Authorization (EUA) submissions for COVID-19 diagnostic tests, personal protective equipment (PPE) decontamination systems, and Mpox diagnostic tests
- Represented national industry association in meetings with FDA leadership regarding medical device and radiation-emitting electronic product rulemakings
- Assisted drug and medical device manufacturers in preparing responses to FDA Form 483 Observations and Warning Letters
- Successfully represented drug manufacturer in internal appeal of FDA determination that certain drug products were allegedly “adulterated”
- Aided in drafting request for a hearing in response to FDA’s Notice of Opportunity for Hearing, proposing to withdraw approval of certain new animal drug applications (NADAs)
- Conducted large-scale, internal assessment of global drug company’s manufacturing division
- Represented client in FDA, Drug Enforcement Administration (DEA), and state regulatory-related due diligence for $170 million acquisition of legacy drug and medical device products as well as manufacturing facility
- Assisted global drug company in internal review of policies and procedures concerning investigator-initiated trials
- Advised manufacturer regarding applicability of and compliance with Maine’s PFAS in products law and New Jersey’s recycled content law
- Represented underwriters in $100 million follow-on offering by surgical robotics medical device company
- Counseled client on U.S. Department of Agriculture (USDA) regulation of veterinary biologics
Conventional Food (Including Beverages), Dietary Supplements, and Cosmetics
- Represented client in FDA appeal challenging federal jurisdiction and requirement to register establishment with FDA as a food facility
- Drafted response to joint-FDA/FTC Warning Letter and conducted internal company trainings regarding FDA and FTC labeling and claims substantiation requirements
- Represented investor in FDA, USDA, and state regulatory-related due diligence for investment as new majority shareholder in one of the largest producers of fresh vegetables in Canada
- Successfully petitioned FDA for removal of cosmetics from import alerts
- Represented client in $250 million acquisition of developer of polymer technologies and polymerization methods for a variety of applications, including food additives, cosmetics, and personal care products
- Reviewed conventional food, dietary supplement, and cosmetic product labeling for compliance with FDA and FTC requirements
- Advised client on the suitability of a specific process for producing post-consumer recycled (PCR) plastic to be used in the manufacturing of food-contact articles
- Assisted conventional food, dietary supplement, and cosmetic manufacturers in navigating FDA and state-specific facility registration requirements
- Counseled national restaurant franchise on FDA’s requirements concerning nutrition labeling of standard menu items
Clinical Laboratories
- Represented industry association before the Division of Clinical Laboratory Improvement & Quality (CMS) concerning various CLIA rulemakings
- Co-drafted legislation signed into law in California and New Jersey regarding the regulation of clinical laboratories
- Represented client before FDA and Congressional committee staff regarding federal diagnostics legislation
- Drafted public comments for CLIA rulemakings and Federal Register Requests for Information (RFIs)
- Assisted in internal investigation of clinical laboratory for compliance with CLIA and FDA regulatory requirements
- Advised clinical laboratories regarding CLIA inspections, including drafting the Plan of Correction in response to Form CMS-2567
- Provided CLIA and FDA-related due diligence in connection with potential acquisition of group of clinical laboratories
- Aided client in transitioning research-and-development facility into a CLIA-certified, high-complexity laboratory
- Counseled laboratories on compliance with Substance Abuse and Mental Health Services Administration (SAMHSA) drug testing mandatory guidelines and forensic toxicology accreditation
- Assisted client in preparing public testimony before the Texas Forensic Science Commission concerning a proposed rulemaking
Pro Bono
- Represented Federally Qualified Health Center (FQHC) in drafting several rounds of FDA public comments and advisory committee public testimony concerning agency blood donation guidelines
- Represented federal inmate in seeking a Presidential clemency grant
- Successfully represented Latin American immigrant in U visa application
- Authored white paper on behalf of global pro bono law firm analyzing how parties become signatories to intrastate peace agreements
- Successfully represented client in obtaining court order to amend birth certificate
Previous Professional Experience
- Counsel, Washington, D.C. office of global law firm (2014–2021)
- Constituent Services (Field Education Placement), U.S. Senate (2008–2010)
- Assistant Director of Undergraduate Admissions, Yale University (2005–2007)
Education
-
Northwestern University School of Law,
JD
(2012)
- Order of the Coif
- Graduated in two years
- Point Foundation Scholarship
- Semester abroad at Bucerius Law School (Germany)
-
Harvard University,
MDiv
(2010)
- Harvard Presidential Scholarship
-
Yale University,
BA
(2005)
- Dupuy Graduation Prize for Scholarship
- Bergin Graduation Prize in the Humanities
- Semester abroad at University of New South Wales (Australia)
Admissions
- South Carolina
- District of Columbia
- U.S. Court of Appeals for the District of Columbia Circuit
- U.S. District Court for the Eastern District of Wisconsin
Practice Areas
Representative Matters
Human and Animal Drugs and Medical Devices (Including Diagnostics)
- Supported medical device manufacturers in regulatory strategy and drafting Emergency Use Authorization (EUA) submissions for COVID-19 diagnostic tests, personal protective equipment (PPE) decontamination systems, and Mpox diagnostic tests
- Represented national industry association in meetings with FDA leadership regarding medical device and radiation-emitting electronic product rulemakings
- Assisted drug and medical device manufacturers in preparing responses to FDA Form 483 Observations and Warning Letters
- Successfully represented drug manufacturer in internal appeal of FDA determination that certain drug products were allegedly “adulterated”
- Aided in drafting request for a hearing in response to FDA’s Notice of Opportunity for Hearing, proposing to withdraw approval of certain new animal drug applications (NADAs)
- Conducted large-scale, internal assessment of global drug company’s manufacturing division
- Represented client in FDA, Drug Enforcement Administration (DEA), and state regulatory-related due diligence for $170 million acquisition of legacy drug and medical device products as well as manufacturing facility
- Assisted global drug company in internal review of policies and procedures concerning investigator-initiated trials
- Advised manufacturer regarding applicability of and compliance with Maine’s PFAS in products law and New Jersey’s recycled content law
- Represented underwriters in $100 million follow-on offering by surgical robotics medical device company
- Counseled client on U.S. Department of Agriculture (USDA) regulation of veterinary biologics
Conventional Food (Including Beverages), Dietary Supplements, and Cosmetics
- Represented client in FDA appeal challenging federal jurisdiction and requirement to register establishment with FDA as a food facility
- Drafted response to joint-FDA/FTC Warning Letter and conducted internal company trainings regarding FDA and FTC labeling and claims substantiation requirements
- Represented investor in FDA, USDA, and state regulatory-related due diligence for investment as new majority shareholder in one of the largest producers of fresh vegetables in Canada
- Successfully petitioned FDA for removal of cosmetics from import alerts
- Represented client in $250 million acquisition of developer of polymer technologies and polymerization methods for a variety of applications, including food additives, cosmetics, and personal care products
- Reviewed conventional food, dietary supplement, and cosmetic product labeling for compliance with FDA and FTC requirements
- Advised client on the suitability of a specific process for producing post-consumer recycled (PCR) plastic to be used in the manufacturing of food-contact articles
- Assisted conventional food, dietary supplement, and cosmetic manufacturers in navigating FDA and state-specific facility registration requirements
- Counseled national restaurant franchise on FDA’s requirements concerning nutrition labeling of standard menu items
Clinical Laboratories
- Represented industry association before the Division of Clinical Laboratory Improvement & Quality (CMS) concerning various CLIA rulemakings
- Co-drafted legislation signed into law in California and New Jersey regarding the regulation of clinical laboratories
- Represented client before FDA and Congressional committee staff regarding federal diagnostics legislation
- Drafted public comments for CLIA rulemakings and Federal Register Requests for Information (RFIs)
- Assisted in internal investigation of clinical laboratory for compliance with CLIA and FDA regulatory requirements
- Advised clinical laboratories regarding CLIA inspections, including drafting the Plan of Correction in response to Form CMS-2567
- Provided CLIA and FDA-related due diligence in connection with potential acquisition of group of clinical laboratories
- Aided client in transitioning research-and-development facility into a CLIA-certified, high-complexity laboratory
- Counseled laboratories on compliance with Substance Abuse and Mental Health Services Administration (SAMHSA) drug testing mandatory guidelines and forensic toxicology accreditation
- Assisted client in preparing public testimony before the Texas Forensic Science Commission concerning a proposed rulemaking
Pro Bono
- Represented Federally Qualified Health Center (FQHC) in drafting several rounds of FDA public comments and advisory committee public testimony concerning agency blood donation guidelines
- Represented federal inmate in seeking a Presidential clemency grant
- Successfully represented Latin American immigrant in U visa application
- Authored white paper on behalf of global pro bono law firm analyzing how parties become signatories to intrastate peace agreements
- Successfully represented client in obtaining court order to amend birth certificate
Previous Professional Experience
- Counsel, Washington, D.C. office of global law firm (2014–2021)
- Constituent Services (Field Education Placement), U.S. Senate (2008–2010)
- Assistant Director of Undergraduate Admissions, Yale University (2005–2007)
Media
Recognitions
- The Best Lawyers in America® Ones to Watch, Technology Law (2023–2024), Health Care Law (2024)
Professional Activities
- Children’s Trust of South Carolina, Board of Trustees (2023–Present)
- SCBIO
- Board of Directors (2023)
- Executive Committee (2021–Present)
- Harvard University, Divinity School Alumni/ae Council
- (Chair, 2016–2017) and Divinity School Bicentennial Host Committee (Co-Chair)
- Yale College, President of the Piedmont Yale Club (2022–Present)
- Leadership South Carolina, Class of 2023
Christopher is the chair of the firm’s FDA Regulatory Compliance & Litigation practice group. He assists clients in tackling their most sophisticated and high-stakes regulatory issues across a range of product categories, including medical devices, human and animal drugs, in vitro diagnostics (IVDs), conventional foods, dietary supplements, cosmetics, radiation-emitting electronic products, and clinical laboratories. He... aids clients in consequential interactions with the U.S. Food and Drug Administration (FDA) as well as other federal, state, and foreign regulatory agencies, such as the Centers for Medicare & Medicaid Services (CMS), the Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC), and the U.S. Department of Agriculture (USDA).
In his advisory practice, Christopher crafts creative and practical solutions for clients. His work also includes drafting FDA regulatory submissions as well as preparing public comments for agency rulemakings, guidance documents, advisory committees, and public policy venues. He provides strategic advice and regulatory due diligence to support corporate transactions and securities filings in the life sciences space. He also has experience counseling in FDA enforcement matters and conducting global internal investigations and audits of biotechnology, pharmaceutical, and medical device companies.
A prolific writer and frequent public speaker, Christopher is the author of “Overview of the Legal Framework for Medical Device Regulation in the United States” in PLI's Medical Devices Law and Regulation Answer Book (2023, 2021, 2019). He serves as the Vice Chair of the Executive Committee of SCBIO, South Carolina’s not-for-profit, public/private life sciences industry association. Christopher is a member of the 2023 class of Leadership South Carolina and serves as the President of the Piedmont Yale Club. In 2023, Governor Henry McMaster appointed Christopher to the Board of Trustees of the Children’s Trust of South Carolina, which is the statewide organization focused on the prevention of child abuse and neglect.
Experience
Following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.Representative Matters
Human and Animal Drugs and Medical Devices (Including Diagnostics)
- Supported medical device manufacturers in regulatory strategy and drafting Emergency Use Authorization (EUA) submissions for COVID-19 diagnostic tests, personal protective equipment (PPE) decontamination systems, and Mpox diagnostic tests
- Represented national industry association in meetings with FDA leadership regarding medical device and radiation-emitting electronic product rulemakings
- Assisted drug and medical device manufacturers in preparing responses to FDA Form 483 Observations and Warning Letters
- Successfully represented drug manufacturer in internal appeal of FDA determination that certain drug products were allegedly “adulterated”
- Aided in drafting request for a hearing in response to FDA’s Notice of Opportunity for Hearing, proposing to withdraw approval of certain new animal drug applications (NADAs)
- Conducted large-scale, internal assessment of global drug company’s manufacturing division
- Represented client in FDA, Drug Enforcement Administration (DEA), and state regulatory-related due diligence for $170 million acquisition of legacy drug and medical device products as well as manufacturing facility
- Assisted global drug company in internal review of policies and procedures concerning investigator-initiated trials
- Advised manufacturer regarding applicability of and compliance with Maine’s PFAS in products law and New Jersey’s recycled content law
- Represented underwriters in $100 million follow-on offering by surgical robotics medical device company
- Counseled client on U.S. Department of Agriculture (USDA) regulation of veterinary biologics
Conventional Food (Including Beverages), Dietary Supplements, and Cosmetics
- Represented client in FDA appeal challenging federal jurisdiction and requirement to register establishment with FDA as a food facility
- Drafted response to joint-FDA/FTC Warning Letter and conducted internal company trainings regarding FDA and FTC labeling and claims substantiation requirements
- Represented investor in FDA, USDA, and state regulatory-related due diligence for investment as new majority shareholder in one of the largest producers of fresh vegetables in Canada
- Successfully petitioned FDA for removal of cosmetics from import alerts
- Represented client in $250 million acquisition of developer of polymer technologies and polymerization methods for a variety of applications, including food additives, cosmetics, and personal care products
- Reviewed conventional food, dietary supplement, and cosmetic product labeling for compliance with FDA and FTC requirements
- Advised client on the suitability of a specific process for producing post-consumer recycled (PCR) plastic to be used in the manufacturing of food-contact articles
- Assisted conventional food, dietary supplement, and cosmetic manufacturers in navigating FDA and state-specific facility registration requirements
- Counseled national restaurant franchise on FDA’s requirements concerning nutrition labeling of standard menu items
Clinical Laboratories
- Represented industry association before the Division of Clinical Laboratory Improvement & Quality (CMS) concerning various CLIA rulemakings
- Co-drafted legislation signed into law in California and New Jersey regarding the regulation of clinical laboratories
- Represented client before FDA and Congressional committee staff regarding federal diagnostics legislation
- Drafted public comments for CLIA rulemakings and Federal Register Requests for Information (RFIs)
- Assisted in internal investigation of clinical laboratory for compliance with CLIA and FDA regulatory requirements
- Advised clinical laboratories regarding CLIA inspections, including drafting the Plan of Correction in response to Form CMS-2567
- Provided CLIA and FDA-related due diligence in connection with potential acquisition of group of clinical laboratories
- Aided client in transitioning research-and-development facility into a CLIA-certified, high-complexity laboratory
- Counseled laboratories on compliance with Substance Abuse and Mental Health Services Administration (SAMHSA) drug testing mandatory guidelines and forensic toxicology accreditation
- Assisted client in preparing public testimony before the Texas Forensic Science Commission concerning a proposed rulemaking
Pro Bono
- Represented Federally Qualified Health Center (FQHC) in drafting several rounds of FDA public comments and advisory committee public testimony concerning agency blood donation guidelines
- Represented federal inmate in seeking a Presidential clemency grant
- Successfully represented Latin American immigrant in U visa application
- Authored white paper on behalf of global pro bono law firm analyzing how parties become signatories to intrastate peace agreements
- Successfully represented client in obtaining court order to amend birth certificate
Previous Professional Experience
- Counsel, Washington, D.C. office of global law firm (2014–2021)
- Constituent Services (Field Education Placement), U.S. Senate (2008–2010)
- Assistant Director of Undergraduate Admissions, Yale University (2005–2007)
Education
-
Northwestern University School of Law,
JD
(2012)
- Order of the Coif
- Graduated in two years
- Point Foundation Scholarship
- Semester abroad at Bucerius Law School (Germany)
-
Harvard University,
MDiv
(2010)
- Harvard Presidential Scholarship
-
Yale University,
BA
(2005)
- Dupuy Graduation Prize for Scholarship
- Bergin Graduation Prize in the Humanities
- Semester abroad at University of New South Wales (Australia)
Admissions
- South Carolina
- District of Columbia
- U.S. Court of Appeals for the District of Columbia Circuit
- U.S. District Court for the Eastern District of Wisconsin
Practice Areas
- FDA Regulatory Compliance & Litigation
- Laboratory Services
- Clinical Research Stage Contracting & Risk Management
Industries
- The Best Lawyers in America® Ones to Watch, Technology Law (2023–2024), Health Care Law (2024)
- Children’s Trust of South Carolina, Board of Trustees (2023–Present)
- SCBIO
- Board of Directors (2023)
- Executive Committee (2021–Present)
- Harvard University, Divinity School Alumni/ae Council
- (Chair, 2016–2017) and Divinity School Bicentennial Host Committee (Co-Chair)
- Yale College, President of the Piedmont Yale Club (2022–Present)
- Leadership South Carolina, Class of 2023
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