Abeba Habtemariam | People | Arnold & Porter

Abeba Habtemariam advises life sciences companies on a range of regulatory, compliance, and legislative matters, with a particular focus on counseling pharmaceutical and medical device manufacturers on compliance with the Federal Food, Drug, and Cosmetic Act. She routinely advises clients on the regulation of medical device software and healthcare IT, premarket approval and clearance strategies, promotional review matters, and cGMP compliance. Abeba also assists clients with responding to FDA and DOJ investigations and enforcement actions.

Prior to joining the firm, Ms. Habtemariam was an associate in the FDA practice of an international law firm, immediately prior to which she worked as a legal fellow at the Association of American Medical Colleges. During law school, Ms. Habtemariam interned as a legal assistant to the President of Eritrea. Prior to attending law school, she was a Research Analyst at the National Association of Public Hospitals, and a Clinical Researcher at Johns Hopkins Hospital and School of Medicine, focusing on Alzheimer’s Disease, Maternal Depression, and Breast Cancer research.

Focus Areas

Experience

Counsels pharmaceutical, medical device, and telecommunications manufacturers on the regulation of healthcare IT products, mobile medical apps, disease management software, and clinical decision support tools.
Advises clients on the regulation of biosimilar and interchangeable biologics under the Biologics Price Competition and Innovation Act of 2009.
Assists manufacturers of pharmaceuticals, biologics, and medical devices with promotional review matters, and serves as the legal representative on promotional review committees.
Provides medical device manufacturers with advice regarding 510(k) and PMA premarket strategies.
Drafts comment letters regarding proposed rulemakings and guidance on behalf of pharmaceutical manufacturers, medical device manufacturers, and trade organizations.

Performs regulatory due diligence in connection with various transactions and Initial Public Offerings involving medical device, biotechnology, and pharmaceutical companies.
Assists manufacturers with responding to Form 483s and Warning Letters, as well as with carrying-out product recalls.
Participated in defending medical device manufacturers against DOJ allegations of FDCA violations.
Conducted a large-scale internal investigation of a pharmaceutical manufacturer’s clinical trials for a compound under development.
Conducted a comprehensive internal compliance audit of an international pharmaceutical company’s manufacturing policies and procedures.
Counseled companies regarding compliance with the Medical Device Excise Tax regulations.
Advised medical device, pharmaceutical, and cosmetic manufacturers on import and export matters, including successfully appealing import detentions.