Amy Leiser is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device group. She advises pharmaceutical, biotechnology and device companies on a variety of regulatory and compliance issues.
Advised on compliance with ClinicalTrials.gov registration and reporting requirements.
Advised on regulatory compliance issues regarding drug listing.
Drafted report about FDA’s expedited programs.
Conducted international survey regarding regulation of biosimilar products.
Advised on development of quality agreements for contract manufacturing.
Articles in the National Law Review database by Amy Leiser