Jessica L. Vaughn, Ph.D. Associate

She works with clients to design and implement strategies to advance through the premarket approval regimen of the U.S. Food and Drug Administration (FDA). Jessica also provides advice on the planning and conduct of clinical trials, as well as the preclinical phase of drug and medical device development. In the post-market setting, Jessica has advised on responses to FDA information requests, Warning Letters, Form 483 observations and recalls. She has worked with both large global companies as well as small startups, and her experience in-house allows her to provide advice that is practical and focused to the specific needs of her clients.

Jessica has supported the planning and drafting of applications to support the approval of pharmaceuticals including investigational new drug applications and new drug applications, and medical devices including De Novo requests and 510(k) applications. She has also drafted and advised on the creation of GRAS notices and requests for designation for human cell and tissue products. Jessica has also requested and participated in numerous meetings with the FDA and other governmental agencies, developing strategies to ensure clients obtain the valuable advice needed to support both product development and fundraising.

In addition to the regulatory aspects of drug and medical device development, Jessica has advised on and conducted FDA-related due diligence on transactions, including mergers and acquisitions and initial public offerings for food, medical device and pharmaceutical products. Her advanced degree and experience as a clinical information manager in the emergency department in an academic medical center allows her to critically assess scientific and clinical data, including preclinical and clinical study reports and adverse event reports.