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Kristie Gurley

Associate

Washington +1 202 662 5454 kgurley@cov.com Download V-card

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Kristie Gurley advises pharmaceutical and biotechnology companies on marketing authorization and market access issues, including with respect to product development, product approval and launch, pricing and reimbursement activities, advertising and promotion, payer communications, value-based contracting, and related areas. Ms. Gurley routinely advises on regulatory compliance and enforcement risk, commercial transactions, and administrative and legislative policy opportunities.

Advising clients on public policy developments and compliance implications for new legislation or regulations, particularly with respect to recent drug pricing initiatives.
Preparing public comments and various submissions to FDA, CMS, and other agencies.
Advising pharmaceutical companies on regulatory strategies for product development, approval, and market access.
Analyzing state and federal regulatory compliance obligations related to contracting, pricing, manufacturing, distribution, prescribing, and dispensing medical products.
Providing strategic regulatory advice in False Claims Act cases and other litigation.
Conducting regulatory due diligence for mergers, acquisitions, and public offerings.

Represents non-profit organizations in various state and federal policy efforts related to research and development, patient access, and healthcare issues.
Represents low income tenants in eviction proceedings before the DC Landlord and Tenant Branch.
Provided regulatory advice to non-profit organization for its sponsorship of Summer Food Service Programs across the United States.

FDA Issues New Guidance for Development of COVID-19 Drugs and Biological Products

On May 11, 2020, the U.S. Food and Drug Administration (“FDA”) issued new guidance on the development of drugs and biologics to treat or prevent COVID-19: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (“Pre-IND Guidance”) and COVID-19: Developing Drugs and Biological ...

CMS Finalizes Rule Expressly Permitting Copay Accumulator Programs

On May 7, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that it had finalized the Notice of Benefit and Payment Parameters for 2021 (“2021 NBPP Final Rule”). The final rule, which will go into effect on July 13, 2020, expressly allows certain health plans to determine, to the extent permitted by state law, whether to count pharmaceutical ...

FDA Reauthorization Act of 2017: Select Drug Provisions

On August 18, 2017, President Donald Trump signed into law the FDA Reauthorization Act of 2017 (FDARA). This law, containing nine titles, reauthorizes and amends the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.

FDA Releases Final Guidance for Industry on Voluntary Qualified Importer Program for Food

On November 10, 2016, the Food and Drug Administration (FDA) released its final guidance for industry on the voluntary qualified importer program (VQIP). The final guidance builds upon draft guidance issued in June 2015, as part of FDA’s implementation of the FDA Food Safety Modernization Act of 2011 (FSMA) mandate to establish a voluntary, fee-based program to ...

FDA Issues Draft Guidance on Voluntary Sodium Reduction Targets

On June 1, 2016, the FDA announced draft guidance on voluntary sodium reduction targets that could have a substantial effect on food manufacturers and restaurants. The Draft Guidance proposes short-term and long-term targets for various categories of commercially processed, packaged, and prepared foods, as well as recommended upper bounds for sodium in each food ...

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Kristie Gurley

Representative Matters

Pro Bono

News and Insights (Showing 5 of 6) (Showing 6 of 6)

FDA Issues New Guidance for Development of COVID-19 Drugs and Biological Products

CMS Finalizes Rule Expressly Permitting Copay Accumulator Programs

FDA Reauthorization Act of 2017: Select Drug Provisions

FDA Releases Final Guidance for Industry on Voluntary Qualified Importer Program for Food

FDA Issues Draft Guidance on Voluntary Sodium Reduction Targets

For the Health of It: How the Quantified Health Benefits of the USDA Nutrition Standards Justify Reauthorization and Increased Funding for School Meal Reimbursement

Practices

Education

Harvard Law School, J.D., 2015

Georgia Institute of Technology, B.S., 2010

Bar Admissions