Expertise in all things FDA
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Expertise in all things FDA
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.