Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. His practice also includes advising clients on research approval, sales, and negotiating contractual relationships.
Benjamin has experience representing medical device companies in responding to significant unfavorable inspection observations, sometimes accompanied by a warning letter. He guides companies with compliance issues through the development stage of action plans and implementing corrective actions.
In his practice, Benjamin participates in the coordination of diligence reviews of transactions involving large pharmaceutical and medical device manufacturers. He is well versed in the process of developing policy positions and submitting comments to the FDA, as well as analyzing and drafting 510(k) applications for submission to the FDA. Benjamin reviews and drafts clinical study agreements for clients, analyzing both clinical study and human factors protocols with respect to legal requirements.
Benjamin has given numerous presentations on current health care industry topics, with titles such as Advertising and Promotion for Drugs, Devices and Biologics Using Social Media and Promotion of Investigational Drugs and Devices. He previously worked as a research chemist in the discovery group of a major research-based health care and pharmaceutical company. While in law school, he held the position of Executive Editor of the Cardozo Law Review.
More Legal and Business Bylines From Benjamin M. Zegarelli
- FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies - (Posted On Tuesday, July 12, 2022)
- FDA Cracks Down on Unauthorized and Counterfeit COVID-19 Diagnostic Tests - (Posted On Monday, May 09, 2022)
- Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started - (Posted On Wednesday, January 05, 2022)
- FDA Issues Draft Device Guidance in Preparation for the End of the Public Health Emergency - (Posted On Monday, December 27, 2021)
- About Face: Laboratory-Developed Tests for COVID-19 Now Subject to EUA Requirements - (Posted On Friday, November 19, 2021)
- Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions - (Posted On Wednesday, October 20, 2021)
- Coverage of FDA’s AI/ML Medical Devices Workshop - Part 2: FDA’s Recent Digital Health Initiatives - (Posted On Tuesday, October 12, 2021)
- Coverage of FDA’s AI/ML Medical Devices Workshop - Part 1: The History of FDA Software Regulation - (Posted On Monday, October 04, 2021)
- Are You a Medical Device Servicer or Remanufacturer? FDA’s New Guidance May Help…Or Not - (Posted On Wednesday, July 21, 2021)
- Bipartisan VALID Act Re-Introduced in Congress: Is Diagnostics Reform on the Horizon? - (Posted On Tuesday, July 13, 2021)