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.

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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.

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Recognitions


  • The Best Lawyers, Ones to Watch, Health Care Law, 2021 to 2022

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

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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