Deborah Cho is an associate in Ropes & Gray’s life sciences and FDA regulatory practice group. Deborah focuses her practice on FDA regulation of pharmaceuticals, biologics, and medical devices.
Prior to joining Ropes & Gray, Deborah worked at the FDA for nearly four years as Associate Chief Counsel for Drugs in the Office of the Chief Counsel. As Associate Chief Counsel for Drugs, Deborah counseled FDA’s Center for Drug Evaluation and Research on generic drugs, biosimilars, and pediatric drug development. Deborah also advised FDA’s Office of Good Clinical Practice on matters related to human subject protection in clinical investigations. During her tenure at the FDA, Deborah received FDA and CDER Group Recognition Awards for the Mvasi Review Team (review of the first biosimilar approved for the treatment of cancer), the Office of the Chief Counsel Biosimilars Team, and the MMA Rule (2016 Hatch-Waxman regulations) Working Group.
While at Harvard Law School, Deborah served as an intern for the HHS Office of the General Counsel in the Centers for Medicare and Medicaid Services (CMS) Division as well as the Centers for Disease Control and Prevention (CDC) Branch. Deborah also interned for the Hon. Roanne Sragow of the Massachusetts District Court.
Experience prior to joining Ropes & Gray includes:
- Counseled FDA’s Center for Drug Evaluation and Research on rulemakings, guidances for industry, and citizen petitions involving regulatory issues related to the development and approval of generic drugs and biosimilars
- Provided advice to FDA on licensure requirements and standards under the Drug Supply Chain Security Act
- Counseled FDA on pediatric drug development and regulatory issues under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
- Advised FDA’s Office of Good Clinical Practice regarding harmonization of the Common Rule and FDA’s human subject protection regulations
- Quoted, “The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics” Pink Sheet (March 23, 2020)
- Co-author, “FDA-FTC Biosimilar Push Clarified Antitrust Stance,” Law360 (February 19, 2020)
- Co-author, “When DOJ Seeks Dismissals Of Life Sciences FCA Cases,” Law360 (December 12, 2019)
- Deborah Cho, Michelle L. McGowan, Jonathan Metcalfe & Richard Sharp, “Expanded Carrier Screening in Reproductive Healthcare: Perspectives from Genetics Professionals,” 28 Human Reproduction 1725 (2013)
- Michelle L. McGowan, Deborah Cho & Richard Sharp, “The Changing Landscape of Carrier Screening: Expanded Technology and Options?,” 23 Health Matrix 14 (2013)
- John West, Shu-Yuan Liao & Deborah Cho, “Angiosarcoma After Breast Conservation: Diagnostic Pitfalls,” 8 Clinical Breast Cancer 94 (2009)
- JD, Harvard Law School, 2015
- MA (Bioethics), Case Western Reserve University, 2012
- BS (Biochemistry), cum laude, University of California, Los Angeles, 2009