October 22, 2019

Krista Hessler Carver

With over a decade of experience, Krista Hessler Carver advises companies in the biotechnology and pharmaceutical industries on complex and high-stakes FDA regulatory and legislative matters and related disputes.

Ms. Carver counsels clients on an array of issues, including biosimilars, orphan drug, and Hatch-Waxman regulatory issues; pediatric testing; regulatory exclusivities and life cycle management strategies; priority review vouchers; risk evaluation and mitigation strategies (REMS); FDA’s expedited programs; clinical trial data confidentiality and transparency; regulation of human cellular, tissue, and cellular and tissue-based products (HCT/Ps); and proprietary naming of pharmaceuticals.

Articles in the National Law Review database by Krista Hessler Carver


Upcoming Legal Education Events

Wednesday, October 23, 2019
Wednesday, October 30, 2019
Wednesday, November 6, 2019
Tuesday, November 12, 2019
Wednesday, November 13, 2019
Wednesday, November 13, 2019
Wednesday, November 13, 2019
Wednesday, December 11, 2019