Hyman Phelps and McNamara
Sara W. Koblitz

(202) 737-9623
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BA, Johns Hopkins University 2006
Political Science with honors

JD, Duke University School of Law 2012
Special Projects Editor, Duke Journal of Constitutional Law & Public Policy

Maryland 2012
District of Columbia 2013

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Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements. Ms. Koblitz also counsels cosmetics, food, and dietary supplement clients, with experience regarding genetically-modified foods, medical foods, food labeling, and dietary supplement claims and substantiation.

Ms. Koblitz has authored several Citizen Petitions and has worked extensively with litigators and experts in preparation for depositions and trial. She has worked with companies of all sizes, from start-ups to fortune 500 companies. Ms. Koblitz also has experience in export control and other areas of regulatory law.

Prior to joining Hyman Phelps & McNamara, Ms. Koblitz practiced at a major intellectual property firm, where she counseled clients on the Hatch-Waxman Act and other areas of FDA regulation. Prior to that she worked on general FDA regulatory matters at an AmLaw 100 firm. While in law school, Ms. Koblitz clerked at the FDA Office of Policy and the Humane Society of the United States.

Speaking Engagements   
•  FDLI/CDRH In-House Training and Intro to Medical Device Course, Overview of Medical Device Law and Regulation, February 3, 2017

Blog Posts    -    see more blog entries
•  FDA’s Getting a Complex,  October 8, 2017
•  FDA’s Approach to Analytical Similarity for Proposed Biosimilars,  September 27, 2017
•  No State Law Allowed: U.S. Weighs in on BPCIA Federal Preemption,  September 14, 2017
•  Discovery in the BPCIA Era: Federal Circuit Rules in Amgen v. Hospira EPOGEN Biosimilar Dispute,  August 13, 2017
•  United States v. Medistat RX LLC Consent Decree: FDA’s Latest Enforcement Effort Related to Compounders and Title I of the Compounding Quality Act,  July 24, 2017