Faegre Drinker announced today that Carolina Wirth joined the firm as counsel in the FDA-regulated products practice in Washington, D.C.
In her practice at Faegre Drinker, Ms. Wirth provides regulatory and strategic counsel to companies involved in the development and marketing of pharmaceuticals, medical devices and animal health products. She works seamlessly with clients to achieve their research and product development goals. She knows the challenges companies face as a result of the pandemic, which has focused the attention of consumers and regulatory agencies on FDA-regulated products. Ms. Wirth is prepared to help find solutions tailored to each client’s needs to thrive in this new environment.
“During these challenging times, our clients are seeking thoughtful advice to address novel issues – Carolina brings exceptional FDA regulatory and Agency experience, which will bolster our team’s clinical research and pharmaceutical capabilities to skillfully serve both domestic and international clients,” said Heili Kim, leader of the firm’s FDA-regulated products practice. “We know Carolina’s skills and experience will provide invaluable counsel to guide FDA-regulated companies through the complex and ever-changing regulatory and compliance landscape.”
With previous experience as regulatory counsel in the Center for Drug Evaluation and Research’s (CDER) Office of Regulatory Policy at the FDA, Ms. Wirth is uniquely equipped to help clients understand the inner workings of the administrative process.
Her work with domestic and international clients on compliance and regulatory concerns in the marketing, labeling, packaging and advertising of prescription and over-the- counter (OTC) drugs, biologics, HCT/Ps, medical devices and animal products benefits from her service as part of the executive team of a veterinary regenerative medicine company.
During her time as senior vice president for regulatory affairs, Ms. Wirth was responsible for the organization’s overall strategy for obtaining FDA approval of veterinary stem cell products for various species and indications. She served as the legal representative for promotional review committees (PRCs) and routinely advises clients on issues related to the advertising and promotion of prescription drugs and medical devices, including review of brand promotional and non-promotional materials targeted to healthcare providers and patients, training materials, competitor issues, and compliance with Federal Trade Commission (FTC) laws and regulations.
Ms. Wirth also counsels clients navigating the clinical trial process — advising regarding data integrity and human subject protection as well as assisting with strategic advice and day-to-day needs for implementation, such as clinical trial agreements and informed consent documents.
During the COVID-19 public health emergency, Ms. Wirth assisted clients in preparing Emergency Use Authorization applications for medical devices and therapeutics, including in vitro diagnostic tests, personal protective equipment and a prophylactic drug product designed to prevent COVID-19.
Wirth earned her Juris Doctor from the Boston University School of Law and her bachelor’s degree from the John Jay College of Criminal Justice, magna cum laude.
Faegre Drinker’s FDA-regulated products practice group partners with stakeholders in the food, pharmaceutical, health and life sciences, and other impacted industries to navigate FDA regulations and agency interactions. From new medical devices and biotechnology to innovative food products and cosmetics, companies turn to the team to guide them through every stage of product development.