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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)
HHS Publishes Notice Exempting Devices from Premarket Review in Final Days of Trump Administration
February 2, 2021, Covington Alert
On January 15, the final Friday of the Trump administration, the Department of Health and Human Services (“HHS”) published in the Federal Register a notice permanently exempting or proposing to exempt 101 medical devices that previously required a premarket clearance under section 510(k) of the Food, Drug & Cosmetic Act (“FDCA”). Under the notice, seven class I ...
August 25, 2020, Covington Alert
On August 19, the Department of Health and Human Services (HHS) announced a new policy concerning laboratory developed tests (LDTs). Under this policy, HHS has determined that the Food and Drug Administration (FDA) must engage in notice-and-comment rulemaking before requiring premarket review of LDTs. Depending on the next steps from HHS and FDA, this ...
May 14, 2020, Covington Alert
The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance in manufacturing during, or in advance of, a declared public health emergency. On May 6, ...
Sponsor and Investigator Responsibilities and Clinical Trial Compliance Issues
April 7, 2020, FDLI Introduction to Medical Device Law and Regulation
March 29, 2020, Covington Alert
Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other ...
February 24, 2020, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2019 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) of the ...
January 21, 2020, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
December 20, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
Sponsor and Investigator Responsibilities and Clinical Trial Compliance Issues
November 13, 2019, FDLI Introduction to Medical Device Law and Regulation
October 17, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
September 12, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In July and August, the Office of Prescription Drug Promotion (OPDP) posted enforcement letters on FDA’s website.
July 18, 2019, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
May 2019, Journal of Medical Device Regulation
March 14, 2019, Covington Alert
This alert is part of a series of alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
January 31, 2019, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2018 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality ...
November 20, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available U.S. Food and Drug Administration (FDA) enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
September 19, 2018, Covington Alert
This alert is part of a series of alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
March 9, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
February 9, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
January 29, 2018, Inside Government Contracts
On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development ...
January 26, 2018, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2017 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation and Research ...
January 9, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
December 12, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
October 10, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
September 20, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
December 22, 2016, Covington Alert
On December 13, 2016, President Obama signed H.R. 34, the 21st Century Cures Act, which became Public Law No. 114-255 (“the Act”). Its enactment represents the culmination of a multi-year bipartisan legislative process spearheaded on the House side by Energy and Commerce Committee Chairman Fred Upton, Ranking Member Frank Pallone, and Rep. Diana DeGette and on ...
- Washington DC Super Lawyers Rising Star, Food and Drug (2019)