Elizabeth focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceutical, medical device, dietary supplement, cosmetics, and food industries as well as pharmacies and distributors. She advises clients on the Food and Drug Administration (FDA) regulations related to labeling, promotions and advertising, securing clearances and approvals for drugs and devices, importing and exporting, and manufacturing practices. Her counseling and compliance support work reaches into several aspects of FDA-regulated companies’ operations.
Beyond FDA matters, Elizabeth’s practice also encompasses administrative and regulatory matters related to the Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and the National Advertising Division of the Better Business Bureau (NAD).
Prior to joining Mintz, Elizabeth was a health law associate in the Washington office of a Wisconsin-based national law firm, where she assisted clients with a wide range of FDA, DEA, and health care fraud and abuse enforcement matters. Earlier, she was a winter associate at that firm.
While earning her law degree, Elizabeth also completed a clerkship at the White House Council on Environmental Quality and clerkships with the Environmental Protection Agency’s Office of the General Counsel and Office of Enforcement and Compliance Assurance. At law school, she served as a note & comment editor of the Catholic University Law Review.
- Catholic University of America (JD, cum laude)
- George Washington University (BA, magna cum laude)
- Worked with the Health and Wellness Compliance Office for a major pharmacy chain to draft new Standard Operating Procedures related to the several aspects of the pharmacy’s controlled substance operations, including prescriptions, distribution, disposal, storage, among others.
- Managed responses to federal and state regulatory requests including subpoenas and Requests for Information (RFIs) for a major drug distributor regarding controlled and non-controlled substance prescriptions and over-the-counter drugs.
- Member, Food and Drug Law Institute
- Member, American Society of Pharmacy Law
- Member, American Bar Association
- Member, Women's Bar Association of the District of Columbia
- Member, Junior Board of Directors & Pro Bono Associate Committee for Network for Victim Recovery of DC (NVRDC)
March 25, 2021 |Blog
News & Press
March 25, 2021 | Blog | By Elizabeth Conti
February 10, 2021 | Blog | By Elizabeth Conti
January 28, 2021 | Blog | By Joanne Hawana, Elizabeth Conti
November 25, 2020 | Blog | By Laurence Freedman, Elizabeth Conti
November 6, 2020 | Blog | By Elizabeth Conti, Joanne Hawana
Key to the proposed rule is the establishment of a “two-option framework” for registrants to deal with ORUSCs: namely, they could (1) decline to ship the ORUSC and immediately file a suspicious order report to DEA’s centralized database, or (2) conduct due diligence into the ORUSC and make a determination about the order’s validity within seven calendar days, among other requirements. DEA is accepting electronic and written comments on the proposed rule through January 4, 2021.