ML Strategies, LLC, a wholly-owned consulting subsidiary of Mintz, has added Food & Drug Administration (FDA) Senior Policy Advisor Aaron L. Josephson as Senior Director. Mr. Josephson will be based in Washington, D.C.
Mr. Josephson brings nearly 10 years of in-house FDA experience developing and implementing pragmatic solutions to policy and programmatic challenges related to FDA-regulated products. For the last four and a half years, Mr. Josephson worked for the FDA’s Center for Devices and Radiological Health. Prior to that role, he worked in both the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.
Through his time with the FDA, Mr. Josephson has firsthand experience coordinating legislative policy development and legislative affairs activities relating to all aspects of FDA regulation and oversight. He has developed legislative and other policy solutions aligned with Center and Agency strategic goals and priorities, including drafting legislation and policy proposals and providing technical assistance to Congress. Working with key Congressional, Administration, and non-government stakeholders, Mr. Josephson negotiated the most recent reauthorization of the medical device user fee program (MDUFA). He has also crafted policy solutions regarding a variety of regulatory policy topics, including improving evidence generation and analysis; inspections, quality, and compliance; surveillance; and premarket review. He has direct experience in the development and implementation of complex laws and programs, including the 21st Century Cures Act, user fee programs, and the FDA Reauthorization Act.
ML Strategies professionals in Boston and Washington, DC use their extensive experience in federal, state, and city government, as well as in the private sector, to build creative, informed, and strategic solutions that meet clients’ goals. The ML Strategies team focuses on a clients in range of industries including energy, transportation, health care, financial services, real estate, education and telecommunications and regularly collaborates with the Mintz team.