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Over twenty years of experience as an FDA regulatory attorney and life sciences industry executive having expertise in pharmaceutical, biotechnology, and medical device law, regulation, and enforcement; development and implementation of corporate ethics & compliance programs; execution of government affairs/public policy plans; and in federal/state regulatory affairs, compliance, and quality systems.
Expertise in FDA law and regulation spans global marketing authorizations, clinical trials and research, advertising & promotion, current good manufacturing practices (CGMP), post-approval requirements, risk management, recalls, audits, investigations, agency inspections, and related matters, including regulatory meetings, injunctions, consent decrees, and civil or criminal investigations.
In the three years since the DQSA’s Compounding Quality Act (CQA) took effect there have been significant legal and regulatory developments in drug compounding. Learn where compounders, FDA, States, Congress, and pharmaceutical companies stand on the many issues affecting this important, yet challenging, practice. Speakers will cover pressing issues such as the still-unsettled office use compounding debate, FDA’s draft guidance on “essentially copies” of approved drugs, the status of FDA’s draft
https://www.fdli.org/2017/05/compounding-still-mix-dqsa-compounding-quality-act-three-years-later/
Maryland State Bar Association, Vol. 4, Issue 1 · Sep 22, 2022 Exploring how FDA is now integrating "Real World Evidence" from clinical trials into regulatory decision making
Boutique law practice exclusively focused on the FDA, EPA, FTC, DEA-regulated sectors with an emphasis on regulatory compliance and enforcement, customs/trade compliance, litigation, and U.S./Intl. business counsel.
Company: Benjamin L. England & Associates, LLC
I worked there from 3/2021 until now
The largest health care and life sciences-focused law firm in the United States recognized as one of the nation’s preeminent health law firms for the past fifty years. Clients include large and small businesses from a wide array of life science disciplines and major health care providers.
Company: Hall, Render, Killian, Heath & Lyman, P.C.
I worked there from 10/2019 until 3/2021
One of the largest global generics purchasing organizations, leading specialty pharmaceutical services provider and the partner with more community and health system pharmacy relationships
Company: AmerisourceBergen Corporation
I worked there from 4/2016 until 10/2019
Top-tier quality & regulatory consultancy of over 500 professionals serving the life science industry including medical device, biologic and pharmaceutical manufacturers worldwide.
Company: Regulatory Compliance Associates, Inc., a Nelson Laboratories Company
I worked there from 12/2013 until 4/2016
Capital diagnostic & monitoring medical device, in-vitro diagnostic, software, pharmaceutical & biotechnology manufacturer
Company: GE Healthcare
I worked there from 6/2011 until 12/2013