Overview


Anisa Mohanty advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing Practice (cGMP) and Quality System requirements. Anisa also assists clients with US Food and Drug Administration (FDA) engagement strategies and responding to FDA administrative and enforcement actions. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions, and other transactions involving FDA-regulated products as well as issues related to disclosure and periodic reporting.

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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

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

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