David Horowitz brings 25 years of combined experience at the FDA and U.S. Department of Health and Human Services (HHS) to help clients anticipate and navigate complex regulatory compliance challenges.

David’s practice focuses on pharmaceutical compliance issues, including Current Good Manufacturing Practice (CGMP), inspections, recalls, post-market reporting, import/export, drug supply chain security, pharmacy issues, and OTC drug issues.  During his time at HHS and FDA, David developed a deep understanding of the institutions, organizational structures, procedures, and cultures through which regulatory policy and compliance decisions are considered, developed, and implemented across all branches of government.  The combination of his deep technical knowledge and years of experience allows David to provide strategic and tactical advice to proactively avoid regulatory problems, as well as respond effectively to unanticipated challenges.

As Deputy General Counsel at HHS (2010-2017), David oversaw and coordinated legal services in support of FDA and other HHS public health agencies. His work focused on FDA regulatory policy and compliance-related issues. During his tenure at FDA – which included five years as head of the Office of Compliance for drugs, and three years as Assistant Commissioner for Compliance Policy – David played a leadership role in numerous major initiatives, including the modernization of FDA's approach to pharmaceutical manufacturing quality and the agency's efforts to develop and implement a more scientific, risk-based approach to inspection and enforcement.  He also led the development of FDA’s first risk-based quantitative model used to prioritize drug manufacturing inspections.

Awards and recognitions


Healthcare: Life Sciences
Legal 500 US


Meritorious Service
Presidential Rank Award


Distinguished Service and Leadership Award
Food and Drug Law Institute


NIH Director's Award

1999, 2007

FDA Award of Merit

1994, 1998, 2005, 2006, 2015

FDA Commissioner's Special Citation

2010, 2015

HHS Certificate of Appreciation


Healthcare: Pharmaceutical/Medical Products Regulatory, Rank 4
Chambers USA

Education and admissions


J.D., University of Virginia School of Law, 1991

B.A., Brown University, magna cum laude, 1986

Bar admissions and qualifications

District of Columbia


Court admissions

U.S. Supreme Court

U.S. Court of Appeals, Fifth Circuit

Representative experience

Advise companies on responding to FDA inspectional observations (483s) and Warning Letters relating to CGMP requirements, resulting in successful resolution of FDA findings.

Assist companies in resolving drug approval issues and FDA complete response letters related to manufacturing quality and GMP concerns.

Provide actionable advice to companies to navigate FDA's complex requirements for importing and exporting biological materials and drug products.

FDA leader in developing internationally harmonized pharmaceuticals guideline on Quality Risk Management, ICH Q9*

*Matter handled prior to joining Hogan Lovells.

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