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Christopher Hanson advises international and domestic clients on regulatory strategies and compliance for medical devices, pharmaceuticals, biological products, cosmetics, animal products, and radiation-emitting electronic products. His broad range of clients include large multinational companies, venture capital firms, industry associations, clinical laboratories, and development-stage companies.
Mr. Hanson has extensive experience counseling clients on interactions with state, federal, and foreign regulatory agencies, including the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC), the Centers for Medicare and Medicaid Services (CMS), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the National Institute for Health and Care Excellence (NICE).
Mr. Hanson regularly assists clients with drafting state, federal, and foreign legislation as well as preparing public comments for agency rulemakings, guidance documents, and advisory committees. He provides strategic advice and regulatory due diligence to support corporate transactions and securities filings. He also has experience advising in enforcement matters and conducting global internal investigations and audits of the firm’s life science clients in the United States, Asia, Australia, Europe, and Latin America.
Mr. Hanson is an active firm member having served as Vice Chair of the Summer Associate Program (2015, 2016) in the Washington, DC office. Additionally, he pursues extensive pro bono work related to the lesbian, gay, bisexual, and transgender (LGBT+) community and speaks across the country on issues of LGBT+ diversity and inclusion in the legal community.
He is a graduate of Northwestern University School of Law, where he was elected to the Order of the Coif and graduated in two years. He holds a Masters of Divinity degree from Harvard University, where he was a Presidential Scholar, and an honors undergraduate degree from Yale University. Mr. Hanson previously served as the Chairperson of the Harvard Divinity School Alumni/ae Council.
- Advised global healthcare company GSK on FDA and CLIA regulatory components of the company's $300 million equity investment and collaboration with genetic testing and data science company 23andMe -- a collaboration focused on R&D of new medicines, using human genetics as the basis for discovery.
- Represent industry association in submitting Congressional Discussion Draft public comments concerning diagnostic tests.
- Prepare industry association public comments concerning the content of risk information in the major statement in DTC prescription drug broadcast advertisements.
- Co-draft legislation successfully signed into law in California and New Jersey concerning the regulation of state clinical laboratories.
- Conduct large-scale, internal assessment of multinational pharmaceutical company’s manufacturing division.
- Prepare public comments and Congressional strategy on behalf of an industry association regarding medical device and radiation-emitting electronic product proposed rulemakings.
- Draft Congressional white paper and request for a hearing in response to FDA’s Notice of Opportunity for Hearing (NOOH), proposing to withdraw approval of certain new animal drug applications (NADAs).
- Draft response to an FDA “It Has Come to Our Attention” (IHCTOA) letter concerning a diagnostic product and prepare FDA Pre-Submission (Pre-Sub) materials.
- Provide FDA regulatory diligence to client for $575 million acquisition of a branded respiratory portfolio.
- Provide FDA regulatory diligence to client for $1.7 billion acquisition of a clinical-stage biopharmaceutical company.
- Advise underwriters in $175 million follow-on public offering of common stock by molecular diagnostics company.
- Represent top global pharmaceutical company in internal review of procedures and policies concerning investigator-initiated trials (IITs).
- Represent client in internal review of procedures and policies concerning cosmetic product labeling.
- Represent industry association in preparing FDA and IOM public comments responding to various draft guidance or study documents concerning clinical trial informed consent, electronic submission of data, clinical trial data sharing, and the use of the Internet/social media.
- Write white papers for clients on proposed legislation involving pharmaceutical and medical device regulation in foreign jurisdictions, including Canada and India.
- Advise industry association regarding FDA regulatory aspects of 21st Century Cures Act.
Pro Bono
- Represent Federally Qualified Health Center (FQHC) in preparing FDA public comments concerning agency blood donation guidelines.
- Represent LGBT organization in litigation involving transgender military service members.
- Successfully represent Latin American immigrant in U visa application.
- Represent LGBT organization in preparation for potential election referendum on state transgender rights law.
- Advise transgender individuals on legal name and gender change procedures in Maryland, Virginia, and Washington, DC.
- Represent federal inmate in seeking a Presidential clemency grant.
- Conduct survey of state Medicaid and prescriptive authority law for health care non-profit.
Memberships and Affiliations
- Medical Device Law Committee of the American Bar Association's Section of Science & Technology Law (Co-Chair)
- Harvard University, Divinity School Alumni/ae Council (Chairperson, 2016-2017) and Divinity School Bicentennial Host Committee (Co-Chair)
- Yale College, Class of 2005 Reunion Chair and Association of Yale Alumni (AYA) Class Representative
- Point Foundation, Wells Fargo Scholar and Mentorship Committee (former)
Previous Experience
- United States Senate, Constituent Services (2008-2010)
- Harvard University, Harvard Humanitarian Initiative Instructor (2008)
- Yale University, Assistant Director of Undergraduate Admissions (2005-2007)
December 14, 2018, Inside Medical Devices
On December 6, FDA Commissioner Gottlieb announced in a press release the availability of a new draft guidance entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” (Draft Guidance). The agency also published the Draft Guidance announcement in the December 7 Federal Register. FDA ...
Informed Consent, Institutional Review Boards, and the Protection of Human Subjects
October 25, 2018, Food and Drug Law Institute's In-House Training Course
FDA Regulation of Medical Devices
October 9, 2018, U.S. Healthcare Compliance Certification Program
July 30, 2018
SILICON VALLEY—Covington advised GlaxoSmithKline on its multi-year collaboration with and $300 million equity investment in 23andMe. GSK will become 23andMe’s exclusive collaborator for drug target discovery programs. The collaboration will focus on research and development of innovative new medicines and potential cures using human genetics as the basis for ...
FDA Regulation of Medical Devices
June 12, 2018, U.S. Healthcare Compliance Certification Program
Informed Consent, Institutional Review Boards, and the Protection of Human Subjects
June 8, 2018, Food and Drug Law Institute's In-House Training Course
January 23, 2018, Inside Medical Devices
On January 22, 2018, President Trump signed legislation delaying implementation of the medical device excise tax for two years. This delay was included as part of a resolution to fund the federal government until February 8 of this year. With broad bipartisan support, the bill passed the Senate (81-18) and the House of Representatives (266-15)....… Continue ...
December 20, 2017, Covington Alert
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...
December 5, 2017, Inside Medical Devices
On October 25, 2017, FDA’s Center for Devices and Radiological Health (CDRH) issued two final guidance documents that provide FDA’s current thinking regarding whether a modification to a 510(k)-cleared device will require the submission of a new 510(k), or may be documented in a “letter to file” as part of the manufacturer’s quality system. Such...… Continue ...
October 17, 2017, Inside Medical Devices
On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs and Devices & Additional Product Classification Issues. This guidance provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product ...
May 19, 2017, Inside Medical Devices
Last week, the Health Care Industry Cybersecurity (HCIC) Task Force (the “Task Force”) published a pre-release copy of its report on improving cybersecurity in the health care industry. The Task Force was established by Congress under the Cybersecurity Act of 2015. The Task Force is charged with addressing challenges in the health care industry “when...… ...
President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces
March 1, 2017, Inside Medical Devices
On February 24, 2017, President Donald Trump signed an executive order entitled “Enforcing the Regulatory Reform Agenda” (the “Order”). The Order is one of several actions the Trump Administration has taken concerning regulatory reform since the presidential inauguration, and directs federal agencies to identify personnel to oversee the implementation of the ...
President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces
February 28, 2017, Covington Alert
On February 24, 2017, President Donald Trump signed an executive order entitled “Enforcing the Regulatory Reform Agenda” (the “Executive Order” or the “Order”). The Order is one of several actions the Trump Administration has taken concerning regulatory reform since inauguration.
January 18, 2017, Inside Medical Devices
On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible ...
January 17, 2017, Covington Alert
On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible ...
January 7, 2017, Inside Medical Devices
On December 28, 2016, CDRH announced the publication of the final guidance “Postmarket Management of Cybersecurity in Medical Devices.” In a separate post, we reported on the January 22, 2016 draft version of this guidance document. The final guidance provides FDA’s recommendations on a risk-based framework for medical device manufacturers to assess and ...
December 6, 2016, Covington Alert
On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, ...
November 20, 2016, Inside Medical Devices
On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014. ...… ...
August 4, 2016, Inside Medical Devices
On July 29, 2016, the FDA announced the medical device user fee rates and payment procedures for fiscal year (“FY”) 2017, which applies from October 1, 2016 through September 30, 2017. The FY 2017 user fees declined from the previous year’s rates. Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), as amended by the...… Continue Reading
September 18, 2015, Covington Alert
August 21, 2014, InsideMedicalDevices Blog
August 18, 2014, Covington E-Alert
June 19, 2014, Covington E-Alert
February 24, 2014, Covington E-Alert
Section 111(d) of the Clean Air Act and State Compliance Flexibilities
January 28, 2014, Center for Clean Air Policy’s Midwest Policy Dialogue
Education
Northwestern University School of Law, J.D., 2012
- Order of the Coif
- Graduated in two years
- Point Foundation Scholarship
- Study abroad at Bucerius Law School (Hamburg, Germany)
Harvard University, M.Div., 2010
- Harvard Presidential Scholarship (2007-2010)
- Resident Tutor (Adams House)
Yale University, B.A., 2005
- Dupuy Graduation Prize for Scholarship
- Bergin Graduation Prize in the Humanities
- Hilgendorf Fellowship (Norway)
- Humanity-in-Action Fellowship (Denmark)
- Association of Yale Alumni Community Service Fellowship (Princeton, NJ)
- Study abroad at University of New South Wales (Sydney, Australia)