Mahnu Davar's practice focuses on assisting FDA-regulated entities with complex regulatory and compliance matters. He has represented early stage medical technology companies, clinical labs, major academic research institutions, and some of the largest multinational drug and device companies in the oncology, ophthalmology, pain, and diabetes care spaces.

Mr. Davar routinely counsels clients on the regulatory and compliance aspects of promotional launch campaigns, clinical research, educational grants and charitable giving, manufacturing and supply chain, deal diligence, and other mission-critical activities. He has conducted significant compliance investigations and audits for business operations in the US, Europe, and Asia, and has extensive experience defending companies in criminal and civil healthcare fraud investigations. He has also assisted clients to prepare for and navigate state and federal regulatory inspections. Mr. Davar's practical approach to counseling in these areas is informed by his experience working first-hand with business leaders as a "secondee" in the legal departments of several leading multinational drug and device companies.

Mr. Davar is a lecturer at the University of Pennsylvania Law School, a Fellow of the Salzburg Global Seminar, and a former Fulbright Scholar to India. Prior to joining the firm, Mr. Davar worked as a law clerk at Wyeth Pharmaceuticals.

Experience

  • Counseling several biopharmaceutical companies in connection with clinical data integrity remediations, including to lead internal investigations, developing regulatory reporting or response strategies, and working with data security consultants to implement CAPAs.
  • Advising several biopharmaceutical companies on regulatory and compliance issues arising from cellular and gene therapy products.
  • FDA, CLIA, and healthcare compliance counsel to several high complexity laboratory technology companies.
  • Counseling several medical technology companies on regulatory and compliance issues arising from real world evidence study design and clinical trial designs.
  • Regulatory and compliance counsel to private equity fund owners of medical technology companies.
  • Assisted senior leadership of several medical technology and biopharmaceutical startups to establish compliance governance infrastructure, including board charters, compliance investigation and non-retaliation procedures, and corporate policies and codes intended to “marry” new business and compliance cultures.
  • Counseling pharmaceutical companies on compliant payor communications and interactions under the new 21st Century Cures legislation.
  • Assisting several biopharmaceutical and medical technology companies to build or enhance healthcare compliance programs, including policies, procedures, training modules, and monitoring systems.
  • Advising several specialty pharmaceutical companies and medical device companies on clinical and pharmacoeconomic research compliance issues, including site contracting, payments to healthcare providers (HCPs) and institutions, GCPs/data integrity, and site inspection readiness.
  • Counseling clinical lab technology companies on FDA and CLIA compliance matters.
  • Representing several pharmaceutical and medical technology companies as FDA/healthcare regulatory deal diligence counsel.
  • Advising major technology and manufacturing company on FDA regulatory implications of set-up of medical device technology subsidiaries.
  • Advising pharmaceutical companies on compliance and disclosure obligations under Corporate Integrity Agreements, Deferred Prosecution Agreements, and Consent Orders/Decrees.
  • Counseling pharmaceutical and medical device companies in connection with regulatory and compliance aspects of significant contract manufacturing, contract research, and product distribution arrangements.
  • Led compliance risks assessments of sales, managed markets, medical affairs, and R&D operations for several biopharmaceutical companies.
  • Represented pharmaceutical manufacturers, medical device manufacturers and distributors, medical technology developers, clinical lab, and major academic research institution in connection with routine and for-cause cGMP, QSR, BIMO, and CLIA inspections.
  • Conducted significant multinational compliance review of biopharmaceutical company's medical, R&D, and drug safety functions.
  • Helped lead training programs for hundreds of employees across Finance, Legal, Compliance, and business functions in Europe, Asia, and the Americas in connection with anticorruption program development and implementation.

Perspectives

United States: Legal and Regulatory Framework
Risk & Compliance Management 2019
Data and Its Impact on Medical Technology Companies Doing Business in the EU
Arnold & Porter Webinar
USA Chapter (pdf)
International Comparative Legal Guide to: Pharmaceutical Advertising 2019, 16th Edition
DOJ Issues New Guidance on Evaluating the Effectiveness of Compliance Programs
Advisory
Center for Devices and Radiological Health (CDRH)
FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law, Washington, DC
More

Recognition

The Legal 500 US
"Next Generation Lawyer" – Healthcare: Life Sciences (2017-2019)
Healthcare: Service Providers (2017)
Washington, DC Super Lawyers
"Rising Star" – Food and Drugs; Health Care (2013-2017)

Credentials

Education
  • JD, University of Pennsylvania Law School, 2007
  • MA, University of Pennsylvania Center for Bioethics, 2007
  • BA, Johns Hopkins University, 2003, with honors, Phi Beta Kappa
  • Fulbright Scholar, India
Admissions
  • District of Columbia
  • Pennsylvania
  • US District Court, Eastern District of Pennsylvania
Activities
  • Member, The District of Columbia Bar, Health Law Section

  • Fellow, Salzburg Global Seminar

  • Lecturer in Law, University of Pennsylvania Law School

  • Fellow, Leadership Council on Legal Diversity (LCLD)
Languages
  • Hindi
  • Spanish
Overview

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