About
Bar admissions / Professional QualificationsDistrict of ColumbiaNorth Carolina
Anisa Mohanty . . . is a highly skilled healthcare attorney who provides excellent legal advice.
— The Legal 500

EXPERIENCE

  • Assisted a global corporation with the successful execution of an advertising and promotion continuous improvement audit of the multiple medical device companies within the corporate portfolio
  • Partnered with senior leadership and an audit team to perform strategy risk assessments and make targeted improvements to advertising and promotion practices
  • Assisted a pharmaceutical manufacturer with the development and execution of a strategic response to an FDA Untitled Letter related to direct-to-consumer advertising
  • Counseled a private equity firm and coordinated a multi-disciplinary team of cross-border regulatory specialists to conduct FDA regulatory due diligence and develop a risk assessment related to manufacturing operations and promotional practices, including coordinating engagement with a third-party auditor and establishing audit parameters for foreign contract manufacturing operations
  • Provided legal support and review for the promotional review committee of a prescription drug manufacturer, including key promotional pieces, references and substantiation, reprints and product detailing activities
  • Conducted FDA regulatory due diligence and provided legal counsel for an asset purchase regarding the implementation of a transition services agreement for a multinational prescription drug manufacturer
  • Advised an early-stage digital health company on the FDA market pathways and regulatory status of a clinical decision support (CDS) tool
  • Developed the internal institutional review board policies, procedures, and forms for a global nonprofit
  • Counseled a digital health company on patient registry protocol, informed consent and research services agreements
  • Conducted investigation regarding FDA compliance in connection with potential whistleblower claim on behalf of board of biotechnology company

AWARDS AND RECOGNITION

Chambers USA

  • Up and Coming, District of Columbia Healthcare: Pharmaceutical/Medical Products Regulatory, (2025)

The Legal 500 United States

  • Leading Associate, Life Sciences, (2025)
  • Rising Star, Life Sciences, (2023 – 2024)
Additional Recognitions
  • Rising Star Award, Food and Drug Law Institute, (2024)
  • Ones to Watch®, Best Lawyers, (2021 – 2023)

Pro Bono

  • MedTech Color Collaborative Community, Budget and Finance Committee
Education
  • J.D., University of Richmond School of Law
  • B.A., University of North Carolina at Chapel Hill

Publications and media

  • "FDA Issues Good Machine Learning Practice Guiding Principles," The Journal of Robotics, Artificial Intelligence & Law, Volume 5, No. 2 (Mar. - Apr. 2022)

Seminars

  • FDLI Advertising and Promotion for Medical Products Conference, Moderator, How to Harness the Transformative Power of MLR in Promotional Review (Oct. 2024)
  • MassMedic - FDA Digital Health & IP (May 2023)
  • FDLI, Introduction to Medical Device Law and Regulation: Clinical Investigations (Nov. 2022, Apr. 2024)
  • FDA Update: Evolving Rules for Clinical Decision Support Software and Use of Digital Tools for Clinical Research (Nov. 2022)
  • Health Tech X (HTX) (panel moderator) – "Growing smartly: Variances in value from pre-series A to PE" (Nov. 2022)
  • AdvaMed MedTech 2022 - U.S. Market Access Seminar: Planning Regulatory & Reimbursement Pathways: How to Find Your Most Efficient Way to Market (Oct. 2022)
  • Stanford BioDesign: Healthcare and Life Sciences Start-Ups: Legal & Regulatory Considerations 101 (Oct. 2022)
  • Georgetown Law First-Year Program: Practice Area Series - FDA/Health Law (Oct. 2022)
  • 2022 Cross-Border M&A and Private Equity Conference (MuMAC 2022) (Munich) Life Sciences Panel ("Trends and disruptions in the life sciences sector – are we making the most of these highly innovative times?") (Sept. 2022)
  • FDLI, Introduction to Medical Device Law: Clinical Investigations (April 2019)

Prior Experience

Prior to working at DLA, Anisa was a member of the Health practice for a major AmLaw 25 international law firm. Anisa also served as an intern for the North Carolina Department of Justice, the U.S. Department of Health and Human Services, and Virginia Commonwealth University, where she handled various matters related to administrative hearings, appellate proceedings, and legislative processes.

Memberships and Affiliations

  • MedtechWomen / MedtechVISION
  • Food and Drug Law Institute, Advertising and Promotion of Medical Products Conference Planning Committee, 2024
  • Food and Drug Law Institute, Medical Products Committee, 2025
  • American Health Lawyers Association
  • South Asian Bar Association of Washington, D.C.

My latest insights

Publication

Presidential Memorandum on DTC prescription drug advertising signals increased focus on...

12 September 2025 .12 minute read

Publication

Key takeaways from FDA’s draft guidance on use of AI in drug and biological life cycle

23 January 2025 .10 minute read

Publication

FDA issues Artificial Intelligence-Enabled Device Software Functions draft guidance

15 January 2025 .14 minute read

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Phone

+1 202 799 4423
(Work, Washington, DC)