Our Website Uses Cookies 


We and the third parties that provide content, functionality, or business services on our website may use cookies to collect information about your browsing activities in order to provide you with more relevant content and promotional materials, on and off the website, and help us understand your interests and improve the website.


For more information, please contact us or consult our Privacy Notice.

Your binder contains too many pages, the maximum is 40.

We are unable to add this page to your binder, please try again later.

This page has been added to your binder.

Allison Whelan is an associate in the firm’s Food, Drug, and Device Practice Group. She works with health care, pharmaceutical, medical device, and food clients on a wide range of complex regulatory and compliance matters.

Ms. Whelan advises pharmaceutical companies on regulatory strategies for clinical stage development and regulatory approval, promotional materials, and healthcare fraud and abuse risks. She also advises companies on the domestic and international development, approval, and promotion of medical countermeasures, including access to investigational products during public health emergencies. On the compliance front, Ms. Whelan assists companies with the development and implementation of health care compliance policies and procedures, and provides FDA regulatory and health care compliance strategies during litigation, internal investigations, mergers and acquisitions, and public offerings.

  • Regularly advises pharmaceutical companies on regulatory strategies for clinical stage development and regulatory approval, including breakthrough therapy designation and accelerated approval.
  • Advises specialty biopharmaceutical companies on the domestic and international development, approval, and promotion of medical countermeasures.
  • Provides ongoing legal and strategic advice to companies considering Emergency Use Authorizations for investigational products during and in advance of public health emergencies.
  • Drafts and advises on the development of company healthcare compliance policies, procedures, and codes of conduct.
  • Provides legal review of pharmaceutical companies’ promotional materials as a member of the companies’ Medical, Legal, and Regulatory review committees.
  • Assists with legal and regulatory reviews of patient support programs during major acquisitions.

Pro Bono

  • Advised a non-profit reproductive advocacy organization on lobbying and legislative strategies.
  • Drafted amicus briefs on behalf of the Gifford Law Center to Prevent Gun Violence in support of the constitutionality of restrictions on concealed carry of loaded firearms.
  • Assisted elderly clients with Medicare enrollment.

Memberships and Affiliations

  • American Bar Association
  • American Health Lawyers Association

Previous Experience

  • Guest Lecturer, Michigan State University College of Law, Institute for Food Laws & Regulations (2017)
  • Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law (2015)