Sarah advises medical products companies developing and manufacturing pharmaceuticals, biologics, and medical devices on issues where FDA regulatory and compliance matters intersect with strategic business decision-making. She specifically focuses on providing FDA regulatory and compliance counsel to medical products clients on a variety of matters, including Good Clinical Practice and clinical trials, pharmacovigilance, medical communications and health care economic information, Good Manufacturing Practice (drugs and medical devices), advertising and promotion, patient support programs, and ClinicalTrials.gov registration and reporting. She has also written and spoken extensively on clinical trial modernization and diversity, in addition to the implications of the recent Food and Drug Omnibus Reform Act (FDORA) and current draft FDA guidance.
Qualifications
Récompenses et distinctions
- Named to list of Top 40 Under 40 in Texas by The National Black Lawyers (2021- 2023)
- Selected to participate in the Leadership Council on Legal Diversity Pathfinders program (2021)
- Selected to Thomson Reuters’ “Super Lawyers - Rising Stars” List (2023)
- Selected to Super Lawyers Texas Rising Stars list for Health Care (2024)
Notable quotes
- 9 November 2024 "As AI Transforms Drug Development, FDA Is Scrambling to Figure Out Guardrails" Law.com
- 29 June 2024 “Supreme Court’s gutting of Chevron doctrine could mean headaches for drug industry” STAT
- 13 May 2024 “FDA Lab Test Authority Set for Compliance Hurdles, Legal Fights ” Bloomberg Law
- 29 March 2024 “Joe Biden is in a race against the clock to cement his health care legacy” PoliticoPro
- 19 January 2023 “Diversity in Clinical Trials at FDA Gets a Boost From New Law,” Bloomberg Law
- 30 September 2023 “BRIEF—US government shutdown and FDA impact on pharma - update,” The Pharma Letter