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Cori Annapolen Goldberg


Cori Annapolen Goldberg

New York

T:+1 212 318 3424

Washington, DC

T:+1 202 662 0436

Cori Annapolen Goldberg focuses her practice on FDA issues for the food, drug, and medical device industries; health law matters; government and internal investigations; and white collar criminal defense.  Cori has regulatory, investigational, and transactional expertise.  She has worked with clients including medical device manufacturers, pharmaceutical companies, food manufacturers, hospitals, academic medical centers, physicians, and other health care providers. Her practice includes the representation of clients in compliance matters, including internal investigations and self-disclosures.  She also advises clients on issues related to accreditation by the Accreditation Council for Graduate Medical Education (ACGME) and the Liaison Committee on Medical Education (LCME).

Cori advises her clients on food and drug law issues, including FSMA implementation and food safety concerns; clinical research considerations; corporate compliance concerns; and fraud and abuse issues. She also represents large corporations in investigations by the US Department of Justice, the US Food and Drug Administration, US Department of Health and Human Services Office of Inspector General, the US Securities and Exchange Commission, and other federal and state agencies.

Prior to joining, Cori served as a judicial law clerk to Judge Clayton Greene, Jr. on the Court of Appeals of Maryland.

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  • Education

    JD, cum laude, Certificate in Health Law, University of Maryland School of Law, 2006
    MPH, University of Maryland School of Medicine, 2006
    BA, Sociology, Emory University, 2003

    As an undergraduate, Cori was on the Dean's List, and was a member of the Alpha Kappa Delta Sociology Honor Society, the Alpha Epsilon Delta Science Honor Society, and the National Society for Collegiate Scholars. In law school, she served as a Notes and Comments Editor for the Maryland Law Review, was on the National Health Law Moot Court Team, and was a member of the Student Health Law Organization. Cori received first place in the 2005 George Washington University Legal Research and Writing Competition and was awarded the William P. Cunningham Award for exceptional achievements and service to the school.  She also worked as a Teaching Assistant and Writing Fellow.

    Cori is admitted to practice law in New York, Washington, D.C. and Maryland. She is also admitted to the United States District Court for the District of Maryland.

  • Representative experience
    • Advises grocery stores and other food retailers about important developments in food regulation including Food Safety Modernization Act (FSMA) final rules and implementation considerations, standards on gluten-free labeling and bioengineered foods, FDA's Retail Food Safety Action Plan, Retail and Food Service Hazard Analysis and Critical Control Points, recalls, Warning Letters, scrutiny of caffeine and energy drinks, and "natural" claims
    • Assists food manufacturers with FSMA registration and implementation, Nutrition Fact Panel labeling requirements, and GMO labeling requirements
    • Advises food manufacturers about potential misbranding issues
    • Advises natural and organic grocers about labeling issues for allergens and vegan/vegetarian products
    • Advises natural and organic grocers about federal and state considerations for delivery of food products
    • Reviews advertisements to ensure that they comply with FDA requirements
    • Advises cosmetic companies about labeling requirements, including necessary warning statements for certain products
    • Advises companies about country-of-origin and other labeling requirements
    • Drafts healthcare and FDA representations and warranties for medical device and pharmaceutical companies in M&A transactions
    • Supports clients during FDA inspections and prepares responses to 483s
    • Assists clients with product recalls
    • Represented an orthopedic device company in its $375 million sale to a global medical technology company in its FDA regulatory matters
    • Advises medical device companies about FDA reporting obligations under 21 C.F.R. Part 806
    • Creates and implements compliance programs
    • Prepares clinical trial agreements and consulting agreements
    • Advises clients about financial conflicts-of-interest issues, IRB requirements, fraud and abuse issues, and other compliance issues in clinical trials
    • Represents large health systems and private research universities in connection with clinical research misconduct investigations involving research grants awarded by and issues implicating various federal agencies including NIH, NIMH, OHRP, and FDA.
    • Advises medical device companies about the provision of consulting services including pre-authorization services, coding advice, and other reimbursement assistance
    • Counsels institutions and teaching programs on compliance with ACGME and Residency Review Committee (RRC) requirements and medical schools on compliance with LCME standards
    • Assists clients with voluntary disclosure to CMS of potential Stark Law violations and to OIG of potential Anti-Kickback Statute violations
    • Reviews pharmacies' continuing education programs for possible off-label promotion issues
    • Assists pharmaceutical companies with transfer of IND responsibilities to contract research organizations
    • Advises Pharmacy Benefit Manager about prior authorization and mail-order signature requirements in various states
    • Advises medical education software company about FDA requirements concerning the provision to patients of Consumer Medical Information, Medication Guides, and Side Effect Statements
    • Handles reinstatement of physicians who have been excluded from participating in the Medicare program
    • Provides guidance regarding states' generic drug and device substitution laws
  • Admissions
    • District of Columbia Bar
    • Maryland State Bar
    • New York State Bar
  • Rankings and recognitions
    • Global Inclusion Award Recipient, Norton Rose Fulbright, 2017
    • Rising Star, NY Metro Super Lawyers - Food & Drugs, Thompson Reuters, 2016
    • Rising Star, Healthcare Businesswomen's Association, 2011
  • Publications
  • Speaking engagements
  • Memberships and activities
    • New York State Bar Association - Food, Drug & Cosmetic Law Section
      • Member, Committee on Food Law
    • National Association of Women Lawyers (NAWL)
      • Member, Women in Compliance Practice Area Affinity Group
    • Healthcare Businesswomen's Association
      • Mid-Atlantic Executive Board of Directors, President-Elect (2012)
      • Mid-Atlantic Board of Directors, Director-at-Large, Programming (2011)
      • Mid-Atlantic Chapter, Event Coordinator (2010)
    • American Health Lawyers' Association