Carolina M. Wirth Email & Phone Number

Washington, District Of Columbia, United States

Washington Dc-Baltimore Area

Washington, District Of Columbia, United States

Washington D.C. Metro Area

Moved to AGG with IP Team from Porzio.

Washington D.C. Metro Area

Provided Food and Drug Administration (FDA) regulatory counseling to clients (international and domestic) involved in the medical device, food, dietary supplement, biologics, prescription and Over-the-Counter (OTC) drug Industries. I have experience working clients on a variety of matters, such as:• FDA regulation of Mobile Medical Applications (MMA).• Medical Devices Clearances / Approvals, including preparation of 513(g) and 510(k) submissions.• Review of food labels and claims for compliance with FDA laws and regualtions.• Review of labels, advertising and claims for dietary supplements, OTC drugs and Homeopathic drugs.• Submission and Maintenance of Drug Master Files (DFMs).• Applicability of the Drug Supply Chain Security Act (DSCSA) and Food Modernization Safety Act (FMSA).• Due Diligence involving the sale and acquisition of FDA-regulated entities.• Applicability and compliance with Proposition 65.• Responding to FDA 483s and Warning Letters• Serving as U.S. Agent for foreign medical device and drug manufacturers.• National Advertising Division (NAD) and Federal Trade Commission (FTC) advertising challenges.

Washington D.C. Metro Area

I provided Food and Drug Administration (FDA) regulatory counseling to clients (international and domestic) involved in the medical device, food, dietary supplement, biologics, prescription and Over-the-Counter (OTC) drug Industries.

Silver Spring, Maryland

Ms. Wirth was a Regulatory Counsel within the Office of Regulatory Policy (ORP) of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). While at ORP, Ms. Wirth participated in rulemakings, the development and drafting of guidance documents, and worked with various CDER Offices in responding to Citizen Petitions. Ms. Wirth worked on a variety of matters, ranging from issues related to bioequivalence of generic drugs, to the marketing of OTC drugs approved under a New Drug Application. While at the FDA, Ms. Wirth received a team award for work as part of the Office of Generic Drugs Bupropion Working Group for a comprehensive, coordinated scientific and communication response to reports of lack of efficacy of an approved generic version of bupropion extended release tablets.

Carolina M. Wirth concentrated her practice on issues pertaining to food, drugs, medical devices and cosmetics, with a particular focus on legal and regulatory issues relating to the conduct of clinical trials. Mrs. Wirth counseled institutional review boards (IRBs), clinical investigators, contract research organizations (CROs), and sponsors on contractual and compliance issues. Mrs. Wirth also advised clients on compliance issues associated with the labeling and advertising of drugs, cosmetics, and dietary supplements.