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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 and compliance issues.
- Advise on compliance with ClinicalTrials.gov registration and reporting requirements.
- Advise on regulatory compliance issues regarding drug listing.
- Advise pharmaceutical company on regulatory strategy for clinical stage biological product.
- Draft white papers regarding application of FDA’s expedited programs.
- Conduct international surveys regarding regulation of biosimilar products and medical devices.
- Draft advocacy letter regarding implementation of biological reference product exclusivity law and draft request for reference product exclusivity.
- 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 of drugs and biologics.
- Draft responses to foreign and domestic health regulatory authority enforcement letters.
- Support regulatory due diligences for medical products companies.
Pro Bono
- Represented Federally Qualified Health Center (FQHC) in preparing public comments concerning FDA blood donation guidelines.
- Advised non-profit organization on redistricting laws and procedures in various states.
- Conducted survey of state Medicaid and prescriptive authority laws for health care non-profit.
- Represented national advocacy organization in judicial vetting matter.
- Successfully represented individual seeking criminal record expunction in Maryland.
Previous Experience
- Merck & Co. Inc., Associate Specialist, Engineering (2012-2013)
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)