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

Cooley Shortlisted Across Multiple Categories by LMG Life Sciences Americas

The firm was shortlisted for FDA Litigation and Enforcement Firm of the Year. Individual shortlist selections included Sonia Nath for Regulatory Attorney of the Year – FDA Medical Devices, and Eric Greig for Regulatory Attorney of the Year – Pricing and Reimbursement.

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.

Will AI Be Your New Doctor? Probably Not, Thanks to Recent Trends in State Regulation

As the use of AI becomes increasingly commonplace, some have raised concerns about its use in medicine, particularly when AI assumes a role traditionally held by a physician or other licensed healthcare professional.

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.

Compliance Implications for Healthcare Companies Post-First Circuit Decision

In the case, the US Court of Appeals for the First Circuit adopted the more stringent “but-for” causation standard for claims under the False Claims Act predicated on violations of the Anti-Kickback Statute.

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.

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.

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

Cooley Releases Artificial Intelligence/Machine Learning Medical Device Regulatory Handbook

Our handbook is tailored for device software manufacturers navigating the complex regulatory issues surrounding patient access to innovative medical device technologies.