Aaron is based in our Washington, DC office and is a Senior Director of ML Strategies. He advises clients on health care policy issues related to medical devices and pharmaceuticals.
Prior to joining ML Strategies, Aaron spent 10 years with the US Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health where he led legislative policy development activities related to all aspects of medical device regulation and oversight. He also apprised members of Congress and their staffs about FDA policies and programs and advised multiple FDA Commissioners and other senior officials on strategy and content for meetings with Congress, industry representatives, and other stakeholders. In addition to negotiating the reauthorization of the medical device user fee program (MDUFA), Aaron led FDA’s implementation of key provisions of the 21st Century Cures Act and the FDA Reauthorization Act.
Earlier, Aaron was a budget analyst in the FDA’s Center for Drug Evaluation and Research, where he developed the center’s annual budget and provided information to the Congressional Budget Office (CBO) and congressional authorizers. He began his FDA career in the Center for Biologics Evaluation and Research as an information management specialist responsible for data analyses to support FDA policies and programs.
During his tenure with the FDA, Aaron won numerous agency awards, including the Lireka P. Joseph Award for Excellence in Public Health Communication or Education. He also received special recognition from multiple FDA Commissioners, including a June 2017 special citation for outstanding and sustained performance in the negotiation and reauthorization of MDUFA IV and an August 2016 award for contributions to the 21st Century Cures Act.
Aaron earned a master’s certificate in project management from the George Washington University School of Business and is certified by the American Society for Quality as a quality improvement associate.
- Johns Hopkins University (MS)
- University of Virginia (BA)
August 23, 2019|Blog
News & Press
Share in discussions with Suzanne Schwartz, Acting Deputy Center Director for Science at the FDA’s Center for Devices & Radiological Health, Chief Information Security Officers (CISOs) from leading hospitals, and experienced security colleagues on the current landscape, strategic goals, and lessons learned from their own organization’s medical device security journey.
December 5, 2019 | Blog | By Joanne Hawana , Aaron Josephson, Benjamin Zegarelli
August 23, 2019 | Blog | By Rachel Irving Pitts
August 14, 2019 | Blog | By Aaron Josephson, Elizabeth Conti
July 22, 2019 | Blog | By Aaron Josephson
April 1, 2019 | Blog | By Benjamin Zegarelli, Aaron Josephson
When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CDB advice to share with industry attendees.
March 7, 2019 | Blog | By Aaron Josephson
March 6, 2019 | Blog | By Aaron Josephson
February 28, 2019 | Blog | By Aaron Josephson
The proposed De Novo regulation, issued December 5, 2018, would codify into regulation many of the policy and programmatic features of the De Novo program that are currently outlined in guidance documents. Because guidance is nonbinding, FDA is seeking through the proposed regulation to provide structure, clarity, and transparency to the De Novo process in a way that would be binding on De Novo submitters.
February 21, 2019 | Blog | By Aaron Josephson
December 27, 2018 | Blog | By Joanne Hawana , Aaron Josephson, Benjamin Zegarelli
News & Press
October 23, 2019 | Inside Health Policy
September 26, 2019 | MedTechDive
August 20, 2019 | Inside Health Policy
July 25, 2019 | Inside Health Policy
June 12, 2019 | MedCityNews
In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”