Practices

Life Sciences and Healthcare Regulatory

Trusted FDA and healthcare regulatory lawyers counsel across the spectrum of complex FDA, healthcare and life sciences regulatory issues and defend against government enforcement actions

Chambers USA 2025 Recognizes Cooley Lawyers + Practices

Chambers USA 2025 recognized Cooley with 78 practice area rankings and honored 150 Cooley lawyers in their respective fields – with new recognition in the area of healthcare: pharmaceutical/medical products regulatory.

Cooley Enhances Life Sciences and Healthcare Regulatory Capabilities

Stephanie Hales has joined Cooley’s Washington, DC, office as a partner in the firm’s global life sciences and healthcare regulatory practice.

Cooley Strengthens Life Sciences and Healthcare Regulatory Group With Latest FDA Hire

Laura Akowuah joined Cooley’s life sciences and healthcare regulatory practice and global litigation department from the FDA.

Cooley Grows Life Sciences and Healthcare Regulatory Practice With Partner Hire

Eric Greig joined Cooley’s DC office as a partner in the firm’s global life sciences and healthcare regulatory practice.

Better Late Than Never? FDA Receives Long-Awaited Statutory Fix for Orphan Drug Exclusivity in Recent Appropriations Act

ACI’s 44th Annual FDA Boot Camp

Why Cooley

  • Strategic FDA regulatory counsel across the product life cycle

    Our US Food and Drug Administration (FDA) regulatory lawyers advise clients at every stage – from early-stage companies in clinical trials and those seeking FDA approval to established businesses with marketed products. We provide guidance on advertising and promotion, inspection readiness and representation before government agencies.

  • Comprehensive healthcare regulatory guidance

    Our healthcare regulatory lawyers regularly counsel clients on reimbursement, coding and coverage; compliance with various federal and state healthcare laws, including those regulating the corporate practice of medicine; physician payment transparency laws; healthcare data privacy and protection; and licensure and accreditation.

  • Experienced representation in government litigation and investigations

    Our FDA and healthcare lawyers represent clients in federal court litigation involving the government, as well as in government-facing investigations and enforcement actions. We bring deep experience and a strategic approach to resolving complex regulatory disputes.

  • Recognized leaders in FDA and healthcare law

    We are consistently recognized for excellence in life sciences and healthcare by LMG Life Sciences and Chambers.

  • An integrated regulatory solution

    We provide comprehensive and timely guidance through CooleyREG, our innovative approach that brings together regulatory practitioners from across the firm to help clients navigate every regulatory twist and turn.

Read more

The team has strong knowledge of the topics and nuances, great acumen and client relationships, providing a great service level and responsiveness.

Chambers USA, 2025

This content is provided for general informational purposes only, and your access or use of the content does not create an attorney-client relationship between you or your organization and Cooley LLP, Cooley (UK) LLP, or any other affiliated practice or entity (collectively referred to as "Cooley"). By accessing this content, you agree that the information provided does not constitute legal or other professional advice. This content is not a substitute for obtaining legal advice from a qualified attorney licensed in your jurisdiction, and you should not act or refrain from acting based on this content. This content may be changed without notice. It is not guaranteed to be complete, correct or up to date, and it may not reflect the most current legal developments. Prior results do not guarantee a similar outcome. Do not send any confidential information to Cooley, as we do not have any duty to keep any information you provide to us confidential. When advising companies, our attorney-client relationship is with the company, not with any individual. This content may have been generated with the assistance of artificial intelligence (Al) in accordance with our Al Principles, may be considered Attorney Advertising and is subject to our legal notices.