Cori Annapolen Goldberg

Sr. Associate

Fulbright & Jaworski LLP

Cori Annapolen Goldberg

New York

T:+1 212 318 3424

F:+1 212 318 3400

Washington, DC

T:+1 202 662 0200

F:+1 202 662 4643

Cori Annapolen Goldberg joined the firm in 2007. She works from both the New York and Washington, D.C. offices.  As a senior associate, she focuses her practice on food and drug law issues, health law matters, government and internal investigations, and white collar criminal defense. 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.

Cori advises her clients on a broad array of topics including food and drug law issues, clinical research issues, corporate compliance issues, and fraud and abuse issues. She also represents large corporations in investigations by the US Department of Justice, the 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

    2006 - J.D., cum laude, Certificate in Health Law, University of Maryland School of Law
    2006 - M.P.H., University of Maryland School of Medicine
    2003 - B.A., Sociology, Emory University

    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 retail regulation including standards on gluten-free labeling and bioengineered foods, Food Safety Modernization Act proposed and final rules, 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 registration under the new FDA Food Safety Modernization Act
    • 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 companies about country-of-origin and other labeling requirements
    • Drafts healthcare and FDA representations and warranties for medical device companies in M&A transactions
    • Advises medical device companies about FDA reporting obligations under 21 C.F.R. Part 806
    • Represents clients in internal and government investigations
    • Represents clients in fraud and abuse matters
    • Creates and implements compliance programs for device manufacturers
    • Prepares clinical trial agreements and consulting agreements for device manufacturers
    • Advises hospitals and medical device manufacturers about financial conflicts of interest issues, IRB requirements, fraud and abuse issues, and other compliance issues in clinical trials
    • Advises medical device companies about the provision of consulting services including pre-authorization services, coding advice, and other reimbursement assistance
    • Assists clients with voluntary disclosure to CMS of potential Stark Law violations
    • Assists clients with voluntary disclosure 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
    • Conducts litigation risk assessments for medical technology companies related to the launch of a new product
    • Provides guidance regarding states' generic drug and device substitution laws
  • Professional activities
    • 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)
    • New York State Bar Association - Food, Drug & Cosmetic Law Section
    • American Health Lawyers' Association
  • Professional honors
    • Rising Star - Healthcare Businesswomen's Association (2011)
  • Speaking engagements
  • Publications
    • "FDA Releases Strategic Four-Year-Plan for Comment," Norton Rose Fulbright Legal Update, July 2014
    • "FDA Issues Draft Guidance on Distribution of Scientific and Medical Publications," Health Law Update, June 25, 2014
    • "FDA Bans Nutrient Content Claims for Omega-3s," Food Safety Newsletter, May 22, 2014
    • "FDA extends comment period on proposed rule on sanitary transportation," Food Safety Newsletter, May 22, 2014 
    • "FDA Issues Warning Letters Related to Problems with Clinical Trials ," Health Law Update, April 28, 2014
    • "NY and US Government Reach Agreement on Medicaid Waiver," Health Law Update, April 21, 2014
    • "FDA Recognizes Same-Sex Couples in Clinical Trail Regulations," Health Law Update, April 9, 2014
    • "FDA Flexes Its Muscles: A Stronger Stance Against Trans Fats,"The Food and Drug Law Institute - Update Magazine,  March/April 2014
    • "FDA and First Lady Collaborate on Nutrition Labeling Makeover," Food Safety Newsletter, March 20, 2014
    • "FDA Cracks Down on Drug Maker's Facebook Page," Health Law Update, March 20, 2014
    • "OIG Releases FY 2014 Work Plan," Norton Rose Fulbright Legal Update, February 5, 2014
    • "FDA Overhauls Guidance on 'Dear Doctor' Letters for Drug Risks," Health Law Update, January 27, 2014
    • "FDA Takes a Stronger Stand Against Trans Fats," Food Safety Newsletter, November 21, 2013
    • "Government Shutdown likely to Stall FDA's Momentum on FSMA Priorities," Law360.com, Oct. 8, 2013. (Article also available as a client briefing on nortonrosefulbright.com)
    • "FDA Releases Rules for Medical Device Tracking," Health Law Update, September 30, 2013
    • "GAO Report Determines That More Disclosure and Data is Needed to Clarify Impact of USDA's Changes to Poultry and Hog Inspections; Safe Meat and Poultry Act Introduced in Response," Food Safety Newsletter, September 19, 2013
    • "FDA Details Ethics Panel Duties in Clinical Trials," Washington Healthcare Update, September 3, 2013
    • "Congress Introduces Dietary Supplement Labeling Act of 2013," Food Safety Newsletter, August 22, 2013
    • "FDA Issues Final Rule on Gluten-Free Standards," Food Safety Newsletter, August 22, 2013
    • "FDA Warning Letter Update," Food Safety Newsletter, August 22, 2013
    • "FDA Responds to Comments Regarding its Guidance on 'Dear Doctor' letters," Washington Healthcare Update, July 12, 2013
    • "FDA Warning Letter Update," Food Safety Newsletter, June 20, 2013
    • "FDA Warning Letter Update," Food Safety Newsletter, June 18, 2013
    • "FDA Warning Letter Update," Food Safety Update, May 22, 2013
    • "USDA Relaxes Rules Restricting Import of Italian Cured Meat," Food Safety Update, May 22, 2013
    • "FDA Warning Letter Update," Food Safety Update, April 24, 2013
    • "FDA Requests Budget Increase to Implement FSMA," Food Safety Update, April 17, 2013
    • "New Virginia Law Restricts Access to Biosimilars," Washington Health Care Update, April 9, 2013
    • "FDA Warning Letter Update," Food Safety Update, March 22, 2013
    • "Due to New Studies, FDA Reopens Comment Period for Rule on BSE," Food Safety Newsletter, March 22, 2013
    • "FDA Says Sequester Means Fewer Inspections and Increased Risk to Consumers," Food Safety Newsletter, March 22, 2013
    • "D.C. Circuit Affirms that FDA Properly Approved Generics," Washington Health Care Update, March 21, 2013
    • "FDA Issues Final Guidance Addressing Financial Disclosure by Clinical Investigators," Washington Health Care Update, March 18, 2013
    • "Ninth Circuit Upholds Conviction for Publication of Misleading Clinical Trial Results," Washington Health Care Update, March 12, 2013
    • "FDA Issues Proposed Rule to Change Requirements for use of Foreign Clinical Data," Washington Health Care Update, March 4, 2013
    • "FDA Extends Comment Period for Information Collection Provisions Associated with Two FSMA Proposed Rules," Fulbright & Jaworski L.L.P. Food Safety Update, Feb. 22, 2013
    • "FDA Warning Letter Update," Fulbright & Jaworski L.L.P. Food Safety Update, Feb. 22, 2013
    • "FDA Publishes Proposed Rule on Preventive Controls for Food," Fulbright & Jaworski L.L.P. Food Safety Update, Jan. 24, 2013
    • "FDA Vacates First Suspension Order Issued under its FSMA Authority," Fulbright & Jaworski L.L.P. Food Safety Update, Jan. 24, 2013
    • "FDA Warning Letter Update," Fulbright & Jaworski L.L.P. Food Safety Update, Jan. 24, 2013
    • "FDA Suspends First Food Facility Registration Under FSMA Authority," Fulbright & Jaworski L.L.P. Food Safety Update, Dec. 19, 2012
    • Co-author with Frederick Robinson - "Enforcement Trend: A Sharper Focus on Clinical Research," American Health Lawyers Association Fraud and Abuse Newsletter, December 2012
    • "GAO Report Calls for Foreign Oversight of Food Imports in New Food Safety Report," Fulbright & Jaworski L.L.P. Food Safety Update, Nov. 19, 2012
    • "FSMA Food Maker Registration and Renewal Are Now Underway," Fulbright & Jaworski L.L.P. Food Safety Update, Nov. 19, 2012
    • Co-author with John Kelly and Richard Smith, "The Foreign Corrupt Practices Act: The Healthcare Industry is Under the Microscope," AHLA's Practice Group Report: International Healthcare Update, April 13, 2010
    • Co-author with John Kelly, "The Impact of Law Enforcement Trends and Legislative Reform on the Health Care Industry," BNA's Health Care Fraud Report, Vol 13., No. 24, p. 971-74, December 16, 2009
    • Regular contributor to weekly Fulbright Washington Health Care Update
    • "The Custody Battle Over Cryogenically Preserved Embryos after Divorce," 2 M.S.U. Journal of Gender Law 4, Winter Issue 2007
    • "Maternal Smoking During Pregnancy: Legal Responses to the Public Health Crisis," 12 Virginia Journal of Social Policy & Law 744, 2005
    • "The Court of Appeals Paints a New Canvas: Imposing Stricter Standards on Landlords to Abate Lead Paint Poisoning in Children," 64 Maryland Law Review 1268, 2005
  • Licenses
    • Washington D.C. Bar License
    • Maryland State Bar License
    • New York State Bar License