Overview
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. Anisa also supports investors and companies on scoping and 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.
Results
- 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 polices, procedures and forms for a global nonprofit.
- Counseled a digital health company on patient registry protocol, informed consent and research services agreements.
Recognitions
- The Best Lawyers: Ones to Watch in America, Healthcare Law, Washington, DC, 2021 to 2024
Community
- Food and Drug Administration Alumni Association, Finance Committee, Membership Recruitment Committee member
- District of Columbia Bar, Health Law Section, member
- The American Health Lawyers Association, member
- Food and Drug Law Institute, member
- Richmond Journal of Law and the Public Interest (now the Richmond Public Interest Law Review), publications editor, 2009-2010
Credentials
Education
University of Richmond School of Law, JD, 2010
University of North Carolina at Chapel Hill, BA, 2007
Admissions
District of Columbia
North Carolina
