Suchira Ghosh Counsel 202-945-2512
Suchira Ghosh

Overview

Suchira Ghosh provides regulatory counseling and litigation services to clients in the drug, biologics, and medical device industries.  She regularly advises clients on patent and exclusivity issues arising under the Hatch Waxman Act, the Biologics Price Competition and Innovation Act, and the Orphan Drug Act, and litigates disputes arising under these authorities.  Suchira also represents clients before FDA, such as through the dispute resolution process and citizen petitions.  Among other things, her experience includes advising on product lifecycle strategies, counseling on issues that arise from the intersection of FDA and patent laws, performing regulatory due diligence for drug acquisitions, helping sponsors navigate application approval requirements and address deficiency letters, serving as REMS counsel, providing regulatory and promotional advice for HCT/P manufacturers, and drafting comments on FDA and DEA rulemaking.

Law360 has named Suchira a “Rising Star” in Life Sciences.  She is a frequent presenter and commenter on emerging FDA issues.

Suchira began her career a process engineer at Schering Plough where she was responsible for developing the manufacturing processes for new sterile drugs, participating in technology transfer, and conducting site audits.  Prior to joining Hyman, Phelps & McNamara, Suchira was Counsel with a New York law firm where she litigated FDA and patent cases and provided regulatory counseling.  Prior to that she worked as a patent litigator at a boutique IP firm.  Suchira received her J.D. from University of Michigan Law School and her B.S. in Chemical Engineering from Columbia University.  While in law school, she clerked at the Office of Policy in FDA’s Office of the Commissioner.

Education & Admissions

Education

J.D. University of Michigan Law School, 2007
Articles Editor, Michigan Telecommunications and Technology Law Review

B.S. Chemical Engineering, Columbia University, 2000
King’s Crown Leadership Excellence Award

Admissions

New York

U.S. Courts of Appeals for the Fourth Circuit

U.S. District Court Eastern District of New York

U.S. District Court Southern District of New York

U.S. Patent and Trademark Office

Food and Drug Law Institute

New York State Bar Association

Honors & Awards

Law360 Rising Star in Life Sciences (2017)

Speaking Engagements

  • The Connecticut Technology Council’s, “Medical Device Insights”, June 26, 2019
  • FDLI Introduction to Biologics and Biosimilars Law and Regulation, April 2, 2019
  • FDANews, Expediting the Generic Drug Approval Process: FDA’s New Initiatives on Drug Competition, December 6, 2018
  • ACI 32nd Annual FDA Bootcamp, “Follow-On Products: ANDAs and Biosimilars,” September 27, 2018
  • ACI 31st Annual FDA Bootcamp,”Navigating the Approval Process for Drugs and Biologics,” March 8, 2018
  • NYSBA Annual Meeting, Food Drug and Cosmetic Law Section, Moderator, “From Farm to Table – The Future of GMO Plants and Animals”, January 25, 2018
  • Imedex, Advances in Inflammatory Bowel Diseases: Multidisciplinary Approaches to IBD Patient-Centered Care, “Here and Now: Biosimilars for the treatment of IBD,” November 10, 2017
  • FDLI Introduction to Biologics and Biosimilars Law and Regulation, October 4, 2017
  • ACI 29th Annual FDA Boot Camp, “Unique Considerations in the Approval of Combination Products, Companion Diagnostics, and Stem Cell Therapies,” March 23, 2017
  • FDLI Introduction to Drug Law and Regulation, October 20, 2016
  • FDLI CDER Training, “The Abbreviated NDA (ANDA), 505(b)(2) Applications and Patent and Exclusivity Issues,” May 23, 2016
  • NYSBA Annual Meeting, Food Drug and Cosmetic Law Section, Moderator, “Cosmetics Law Update Including Personal Care Products Safety Act & Food Law Update,” January 28, 2016
  • FDLI CDER Training, “The Abbreviated NDA (ANDA), 505(b)(2) Applications and Patent and Exclusivity Issues,” October 20, 2015
  • FDLI Introduction to Drug Law and Regulation, May 29, 2015
  • FXConferences, “The Abbreviated NDA (ANDA), 505(b)(2) Applications and Patent and Exclusivity Issues” (August 2014)
  • FDLI Introduction to Drug Law and Regulation, December 11-12, 2014
  • FDL CDER Training, “The Abbreviated New Drug Application/The 505(b)(2) NDA” and “Patent and Exclusivity Issues,” May 1, 2013
Education

J.D. University of Michigan Law School, 2007
Articles Editor, Michigan Telecommunications and Technology Law Review

B.S. Chemical Engineering, Columbia University, 2000
King’s Crown Leadership Excellence Award

Admissions

New York

U.S. Courts of Appeals for the Fourth Circuit

U.S. District Court Eastern District of New York

U.S. District Court Southern District of New York

U.S. Patent and Trademark Office

Food and Drug Law Institute

New York State Bar Association

Practice Areas
Industries
FDA Regulatory Categories