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Christopher Hanson

Christopher Hanson

Associate
Washington +1 202 662 5977 chanson@cov.com Download V-card

Christopher Hanson advises international and domestic clients on regulatory strategies and compliance for medical devices, pharmaceuticals, biological products, cosmetics, animal products, radiation-emitting electronic products, and laboratories. His broad range of clients include large multinational companies, venture capital firms, industry associations, clinical and forensic 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), and the Centers for Medicare and Medicaid Services (CMS).

  • Advised global healthcare company GSK on FDA and CLIA regulatory components of the company's $300 million equity investment and collaboration with 23andMe.
  • Co-drafted legislation signed into law in California and New Jersey concerning the regulation of state clinical laboratories.
  • Successfully petitioned FDA for removal of certain Class II medical devices from an import alert.
  • Assisted diagnostics manufacturer in preparing a 510(k) notification and receiving FDA premarket clearance for a Class II device.
  • Represented industry association in FDA meetings regarding medical device and radiation-emitting electronic product proposed rulemakings.
  • Drafted 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).
  • Represented industry association before the Division of Clinical Laboratory Improvement & Quality (CMS) and prepared public comments concerning various CLIA proposed rulemakings.
  • Assisted medical device manufacturer in preparing response to FDA Warning Letter and drafting CDRH Pre-Submission (Pre-Sub) materials.
  • Represented industry association in submitting public comments to Congress concerning in vitro diagnostic (IVD) draft legislation.
  • Prepared responses to several FDA “It Has Come to Our Attention” (IHCTOA) letters and represented medical device manufacturers in FDA meetings.
  • Assisted medical device and pharmaceutical manufacturers in preparing initial and follow-up responses to FDA Form 483 Observations.
  • Advised global pharmaceutical company in interactions with California and New York state clinical laboratory regulators.
  • Drafted FDA regulatory expert report and presentation for Swedish arbitration concerning certain Class II medical devices.
  • Provided FDA regulatory diligence to client for $1.7 billion acquisition of a clinical-stage biopharmaceutical company.
  • Prepared public comments and drafted proposed regulations on behalf of client before the Texas Forensic Science Commission.
  • Wrote position papers concerning proposed legislation involving medical device and pharmaceutical regulation in foreign jurisdictions, including Canada and India.
  • Conducted large-scale, internal assessment of global pharmaceutical company’s manufacturing division.
  • Represented top global pharmaceutical company in internal review of procedures and policies concerning investigator-initiated trials (IITs).
  • Led internal review of procedures and policies concerning product labeling for cosmetics manufacturer.

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.
  • Represented LGBT organization in litigation involving transgender military service members.
  • Assisted LGBT organization in preparation for potential election referendum on state transgender rights law.
  • Advised transgender individuals on legal name and gender change procedures in Maryland, Virginia, and Washington, DC.
  • Conducted 50-state survey of Medicaid and prescriptive authority law for health care non-profit.

Memberships and Affiliations

  • 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)