Carolina M. Wirth
Of Counsel
Suite 1000
Biography
Carolina is of counsel in the firm’s Food & Drug practice and is a member of the Dietary Supplements and Pharmaceuticals & Biologics industry teams. She provides clients with FDA regulatory guidance related to food, dietary supplements, drugs, cosmetics, and medical device products.
Carolina’s prior experience as regulatory counsel in CDER’s Office of Regulatory Policy at the FDA and as an in-house lawyer at a biotechnology company has aided her work with domestic and international clients on regulatory issues associated with the marketing, labeling, packaging, and advertising of conventional foods, prescription and over-the- counter (OTC) drugs, cosmetics, and dietary supplements. She also assists clients with Federal Trade Commission (FTC) and Better Business Bureau National Advertising Division inquiries. In addition, Carolina counsels clients on the clinical trial issues, including reviewing informed consent documents and master clinical trial agreements.
Prior to joining AGG, Carolina served as a food and drug regulatory attorney in private practice, including at Am Law 100 and 200 firms. She also served as Senior Vice President for Regulatory Affairs at a veterinary regenerative medicine company, where she was responsible for its overall strategy for obtaining FDA approval of veterinary stem cell products for various species and indications.
Experience
Represented foundation in an advertising challenge at the National Advertising Division (NAD).
Advise Florida-based food manufacturer with regard to labeling and alleged false advertising of soft drinks, juices and dietary supplements.
Serve as U.S. agent for French medical device manufacturer and Canadian-based drug manufacturer of active pharmaceutical ingredients.
Advise Arizona-based cancer research center on regulatory issues such as compounding and the regulations applicable to institutional review boards.
Advise Atlanta-based animal drug manufacturer on FDA registration and listing requirements and indexing of animal drugs.
Advise Florida-based medical device manufacturer on regulatory issues such as designation of a medical device as a humanitarian use Device (HUD) and the submission of a Humanitarian Device Exemption (HDE) application.
Advise South Carolina-based private label distributor of dietary supplements, cosmetics and pet products on issues related to the marketing, labeling and advertising of these products.
Assisted California-based pesticide manufacturer with drafting and negotiating a supply agreement with Massachusetts-based distributor.
Assisted Florida-based dietary supplement company in successfully responding to a FDA warning letter involving various labeling and good manufacturing practices violations.
Assisted large pharmaceutical company with the review and negotiation of clinical trial agreements, informed consent documents, and non-disclosure agreements.
Credentials
- Boston University Law School, Juris Doctor
- John Jay College of Criminal Justice, Bachelor of Science,magna cum laude
- District of Columbia – 2007
- State of New York – 2003
- United States Supreme Court – 2007
- FDA Alumni Association Activities Committee, Member (2018-Present)
- American Bar Association, Section of International Law, Vice Chair, Latin America and Caribbean Committee (2016-2017, 2017-2018)
- International Life Science and Health Law, Committee Member (2017-Present)
- Food and Drug Law Institute, Member (2015-Present)
- Food and Drug Law institute Webinar Committee Member (2018-19)
- Food and Drug Law Institute’s Food and Drug Policy Forum, Editorial Advisory Board, Member (2011-2012)
- University of Florida, College of Pharmacy, Department of Pharmacy Health Care Administration, Associate Affiliate Professor (Fall 2011)
- Spanish
Recognition
- Washington, DC Super Lawyers, Rising Stars, Food and Drugs, 2016-2019
- FDA Team Award – Office of Generic Drugs Bupropion Working Group, 2014
News & Insights
- PublicationsOTC Monograph Fees Announced… Not So Fast!January 22, 2021 | Articles | Arnall Golden Gregory LLP
- PublicationsThe Wait is Over: FDA Publishes Fiscal Year 2021 User Fees for the Over-the-Counter Monograph Drug User Fee ProgramDecember 30, 2020 | Alerts | Arnall Golden Gregory LLP
- PublicationsWill the Next Therapeutic Emergency Use Authorization be for a Vaccine? FDA Announces Additional Steps to Increase Emergency Use Authorization TransparencyNovember 18, 2020 | Articles | Arnall Golden Gregory LLP
COVID-19 Updates
- Prescription Drug Sampling in the Time of Coronavirus: FDA Issues Temporary Policy Allowing for Drug Samples to be Delivered to Various Locations During the COVID-19 Pandemic
- Not So Fast… New Guidance on the Development of COVID-19 Drugs and Biological Products Makes Clear that FDA Will Not Grant Emergency Use Authorization for Most Therapies
- Q&A: The CARES ACT and OTC Drug Reform in 2020
- It is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform
- In the Midst of the COVID-19 Pandemic, FDA Issues Much Needed Guidance on the Distribution of Face Masks and Respirators
- FDA Decision to Suspend On-Site Inspections Shifts Safety Guarantees to Manufacturers
- LIVE Discussion Tonight: COVID-19 Conference Call on Food Stakeholder Guidance, Pending Legislation, Supply Chain and More
- Not So Clean After All: FDA Takes Aim at Manufacturer of OTC Hand Sanitizer Product Line Making Disease Prevention Claims from Ebola to the Flu