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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, legislative, and compliance matters, as well as considerations for strategic engagement with the Food and Drug Administration (FDA). Ms. Leiser 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. She also has particular experience counseling medical device clients on issues surrounding classification, clearance and approval of new devices, postmarket reporting, and domestic and international enforcement actions.
- 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)
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.
FDA Publishes Draft Guidance on Investigational IVDs Used in Therapeutic Product Clinical Trials
December 22, 2017, Inside Medical Devices
On December 18, 2017, FDA announced the availability of a new draft guidance, titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” The draft guidance is intended to inform both product sponsors and IRBs regarding the application of the Investigational Device Exemption (IDE) regulation to investigational in vitro diagnostic ...
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 17, 2017, Inside Medical Devices
On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs and Devices & Additional Product Classification Issues. This guidance provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product ...
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)