Atty. Sara W. Koblitz
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.
Profile Summary
About Sara W. Koblitz at a glance
Sara W. Koblitz is an attorney based in Washington, District of Columbia, practicing at Hyman, Phelps & McNamara PC. Admitted to practice in Maryland, Maryland State Bar Association and District of Columbia, The District of Columbia Bar. Educated at Duke University (J.D., 2013) and Johns Hopkins University (B.A.). Recognitions include Best Lawyers in America — FDA Law (2026). Serands clients in Washington, DC and the surrounding metropolitan area.
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About
- 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
Jurisdictional Context
Why local counsel matters in District of Columbia
Practicing law in District of Columbia. Legal matters in District of Columbia are governed by state-specific rules of civil and criminal procedure, statutes of limitations, and substantive law. Cases originating in Washington are typically filed in the local municipal court or the appropriate District of Columbia state district court, depending on subject matter and amount in controversy. An attorney licensed in District of Columbia brings working knowledge of local procedural deadlines, judicial practices in this andnue, and the substantive law that applies to cases brought here. Out-of-state attorneys generally cannot represent clients in District of Columbia courts without local counsel or pro hac vice admission.
Looking for additional District of Columbia attorneys? Browse all attorneys in Washington or all attorneys in District of Columbia.
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