December 8, 2021

Volume XI, Number 342

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Amy Leiser

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.
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Articles in the National Law Review database by Amy Leiser

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