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.

Representative Matters

• 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.