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HHS limits the use of guidance documents in civil enforcement actions

May 1, 2021

HHS limits the use of guidance documents in civil enforcement actions
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Christopher Hanson

Christopher Hanson

Partner

101 Constitution Avenue, NW
Suite 900
Washington, D.C., 20001
christopher.hanson@nelsonmullins.com

Christopher assists clients in tackling their most sophisticated and high-stakes regulatory issues involving medical devices, in vitro diagnostics (IVDs), clinical laboratories, human and animal drugs, cosmetics, and radiation-emitting electronic products. He has aided clients in interactions with federal, state, and foreign regulatory agencies, including the U.S. Food and Drug Administration (FDA), the Centers for Medicare...

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Christopher assists clients in tackling their most sophisticated and high-stakes regulatory issues involving medical devices, in vitro diagnostics (IVDs), clinical laboratories, human and animal drugs, cosmetics, and radiation-emitting electronic products. He has aided clients in interactions with federal, state, and foreign regulatory agencies, including the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the Federal Trade Commission (FTC).

Christopher crafts creative and practical solutions for clients. His work 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 agency enforcement matters and conducting global internal investigations and audits.

Christopher Hanson

& Medicaid Services (CMS), and the Federal Trade Commission (FTC).

Christopher crafts creative and practical solutions for clients. His work 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 agency enforcement matters and conducting global internal investigations and audits.

Christopher assists clients in tackling their most sophisticated and high-stakes regulatory issues involving medical devices, in vitro diagnostics (IVDs), clinical laboratories, human and animal drugs, cosmetics, and radiation-emitting electronic products. He has aided clients in interactions with federal, state, and foreign regulatory agencies, including the U.S. Food and Drug Administration (FDA), the Centers for Medicare... & Medicaid Services (CMS), and the Federal Trade Commission (FTC).

Christopher crafts creative and practical solutions for clients. His work 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 agency enforcement matters and conducting global internal investigations and audits.

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

  • Supported medical device manufacturers and clinical laboratories in drafting Emergency Use Authorization (EUA) submissions for COVID-19 diagnostic tests as well as personal protective equipment (PPE) decontamination systems
  • Represented industry association in FDA meetings regarding medical device and radiation-emitting electronic product rulemakings
  • Assisted pharmaceutical and medical device manufacturers in preparing responses to FDA Form 483 Observations and Warning Letters
  • Successfully petitioned FDA for removal of cosmetics and medical devices from import alerts
  • Drafted request for a hearing in response to FDA’s Notice of Opportunity for Hearing, proposing to withdraw approval of certain new animal drug applications
  • Conducted large-scale, internal assessment of global pharmaceutical company’s manufacturing division
  • Represented global pharmaceutical company in internal review of policies and procedures concerning investigator-initiated trials
  • Led internal review of product labeling for cosmetics manufacturer
  • Represented industry association before the Division of Clinical Laboratory Improvement & Quality (CMS) and prepared public comments concerning various CLIA rulemakings
  • Co-drafted legislation signed into law in California and New Jersey regarding the regulation of clinical laboratories

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

Previous Professional Experience

  • Special Counsel, Washington, D.C. office of global law firm (2014–2021)
  • Associate, Milwaukee office of national law firm (2012–2013)
  • Yale University, Assistant Director of Undergraduate Admissions (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

  • 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

Industries

  • Harvard University, Divinity School Alumni/ae Council
    • (Chair, 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
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