Anisa Mohanty

Of Counsel

Anisa Mohanty's client service and general level of service is very strong. Her level of sophistication is strong. Her commercial vision is strong. Anisa is an excellent attorney with deep subject matter expertise and an ability to navigate complex client environments. She has provided seamless support and guidance directly to the teams.

client quoted in Chambers USA

Emailanisa.mohanty@us.dlapiper.com

Call+1 202 799 4423

Washington DC

About

Practicing at the forefront of the life sciences industry, Anisa Mohanty advises medical device, biotech, and pharmaceutical companies on US Food and Drug Administration (FDA) premarket strategy and post-market compliance issues, from advertising and promotion to disclosure and periodic reporting. Her experience encompasses such matters as premarket pathways, Good Laboratory Practice and Good Clinical Practice and Good Manufacturing Practice (cGMP) and Quality System requirements.

She offers guidance to her clients on the regulatory requirements and industry standards for the development, creation and review of advertising and promotional materials for drugs and medical devices. She has a particular focus on advising companies on FDA advertising and promotion strategies and compliance processes leveraging her prior experience as a regulatory counsel at FDA.

Anisa also supports investors and companies on scoping and development developing appropriate due diligence strategies for transactions and investments involving FDA-regulated drugs, medical devices, and other products.

Her tenure as a Regulatory Counsel at the FDA now provides valuable perspective for clients in the life sciences industry. During her time with the organization, Anisa advised agency policymakers, regulatory and enforcement personnel on the development and implementation of a new regulatory regime for tobacco products as well as the development of interpretative guidance and regulatory policies. She was also responsible for counseling compliance and enforcement personnel on matters related to product labeling, advertising and marketing; conducting routine and directed inspections of manufacturing establishments and investigations of distribution and marketing activities; and coordinating enforcement actions.

Areas of FocusFDA Regulatory Life Sciences Life Sciences Transactions Healthcare

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

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.