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.
