Mark A. Tobolowsky

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.