Amanda J. Klingler is a partner in the firm’s Washington, D.C., office and is a member of the firm’s FDA and Life Sciences practice. As a partner in our FDA and Life Sciences practice, Amanda advises pharmaceutical and medical device clients in a wide range of regulatory matters, enforcement actions, civil litigation and compliance counseling.
Amanda represents clients in a variety of FDA regulatory matters, enforcement actions, civil litigation, internal investigations and compliance counseling. She also counsels clients on adverse event reporting, quality system and manufacturing processes for drugs and medical devices, factory inspections, recalls, product labeling, and advertising and promotion issues.
Amanda has also assisted in the negotiation and management of several consent decrees of injunction for pharmaceutical, medical device, food companies and compounding pharmacies.
In addition, Amanda is experienced in handling FDA issues in product liability litigation, including the development of supporting evidence, writing briefs, and preparing fact and expert witnesses to testify.