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Amy Leiser is an associate in the firm’s San Francisco office, where she is a member of the Food, Drug, and Device Practice Group. She advises device, pharmaceutical, and biotechnology companies on a variety of regulatory, legislative, and compliance matters, as well as considerations for strategic engagement with the Food and Drug Administration (FDA). Ms. Leiser has particular experience counseling medical device clients on issues surrounding classification, clearance and approval of new devices, postmarket reporting, domestic and international enforcement actions, and regulatory due diligences. She also has particular experience counseling pharmaceutical and biotechnology clients on issues regarding regulatory exclusivities, FDA’s expedited programs, regulation of biosimilars, clinical trial registration and reporting, and manufacturing compliance.

  • Develop comments on legislative proposal for new diagnostic regulatory framework.
  • Analyze proposed legislative amendments to the Food, Drug & Cosmetic Act regarding orphan drugs, regulatory exclusivities, and Hatch-Waxman issues.
  • Develop public comments and other advocacy letters to FDA on issues regarding biosimilar regulation, nonproprietary naming of biologics, implementation of biological reference product exclusivity law, and the 505(b) filing pathway.
  • Develop citizen petition on generic and 505(b)(2) labeling carve-outs.
  • Develop white papers regarding application of FDA’s expedited programs to address public health needs.
  • Conduct international surveys regarding regulation of biosimilar products and medical devices.
  • Support responses to domestic and international enforcement actions, including providing regulatory support for Department of Justice Investigations, drafting responses to FDA warning letters and international regulatory enforcement letters, and advising on FDA 483 responses to manufacturing inspection observations.
  • Conduct internal investigation of pharmaceutical company’s computerized system data management practices.
  • Advise on development of quality agreements and quality agreement templates for contract manufacturing, testing, packaging, and other services for drugs, biologics, and medical devices.
  • Support regulatory due diligences for medical products companies.

Pro Bono

  • Represent Federally Qualified Health Center (FQHC) in preparing public comments concerning FDA blood donation guidelines.
  • Advise non-profit organization on redistricting laws and procedures in various states.
  • Conduct survey of state Medicaid and prescriptive authority laws for health care non-profit.
  • Represent national advocacy organization in judicial vetting matter.
  • Represent individual seeking criminal record expunction in Maryland.
  • Advise DC arts non-profit on corporate compliance.

Previous Experience

  • Merck & Co. Inc., Associate Specialist, Engineering (2012-2013)
  • Washington DC Super Lawyers Rising Star, Food and Drug (2019)