Mark A. Tobolowsky Associate 202-800-6139

Overview

Mark A. Tobolowsky assists clients on a wide range of pre- and post-approval FDA legal and regulatory matters for drugs and biologics, including development strategies, life cycle management, and guiding clients through applicable requirements. Mr. Tobolowsky also provides counsel to clients regarding incentive programs, clinical trial agreements, and FDA submissions. Mr. Tobolowsky helps developers troubleshoot and find creative solutions to unexpected challenges to create as smooth a pathway to success as possible.

Prior to joining the firm, Mr. Tobolowsky worked for over ten years in the FDA legal and regulatory field, primarily at another FDA-focused law firm. Mr. Tobolowsky has worked with pharmaceutical and biotech companies of differing sizes, areas of medicine, and at all different stages of the product lifecycle. He also has experience working directly for a gene therapy company. Mr. Tobolowsky has authored, in whole or in part, citizen petitions, comments on guidance documents, and expedited program applications. He has also drafted and shaped portions of meeting requests, meeting packages, INDs, NDAs, BLAs, and other submissions to the FDA.

Education & Admissions

Education

J.D., Washington University in St. Louis Law School, 2010

B.A. Rice University, 2007

Admissions

District of Columbia
Texas

Experience

  • Provided strategic advice for clients regarding product development, including on topics such as clinical trial design, incentive programs, novel and surrogate endpoints, and marketing exclusivities
  • Drafted, assisted in drafting, or edited a wide variety of FDA submissions and legal filings
  • Helped clients find agreement with FDA on acceptable paths for approval in the face of significant roadblocks
  • Prepared clients for meetings with FDA
  • Devised creative legal arguments for clients for use in both administrative and judicial proceedings or to find optimal path forward in the face of new legislation
  • Provided counsel to medical device clients, including regarding companion diagnostics and strategies for PMA clearance
  • Reviewed and provided feedback on product licenses and other agreements
  • Performed due diligence for clients seeking to invest in FDA-regulated companies
Education

J.D., Washington University in St. Louis Law School, 2010

B.A. Rice University, 2007

Admissions

District of Columbia
Texas

Practice Areas
Industries
FDA Regulatory Categories