FDA Regulatory and Compliance

An Interdisciplinary Team Anchored by Former FDA Counsel

Wilson Sonsini’s Food and Drug Administration (FDA) regulatory attorneys possess firsthand agency experience, including from the Digital Health Center of Excellence, the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER), and hold advanced scientific and public health degrees.
Strategic Counsel for FDA-Regulated Businesses and Their Stakeholders

We represent innovators, founders, executives, investors, service providers, and other stakeholders across diverse industries, including life sciences, biotech, pharmaceuticals, generic drugs, medical devices, AI/ML-enabled medical technologies, mobile apps, diagnostics, research tools, healthtech, digital health, wellness, and consumer products.
Comprehensive FDA Regulatory Counsel Across the Company Life Cycle

From preclinical research and development through commercial launch and exit, our attorneys work across the firm’s Corporate, Patents and Innovations, Technology Transactions, and Life Sciences practices to serve as both regulatory counsel and long-term strategic partners.

Wilson Sonsini's FDA regulatory attorneys counsel clients with respect to the full range of regulatory challenges that arise throughout a company's life cycle—from initial product development and clinical strategy through commercialization, corporate transactions, and post-market compliance.

Our attorneys advise companies across the full spectrum of FDA-regulated products and industries, including:

Biologics and biosimilars
Cell, tissue, and gene therapies
Clinical decision support products and platforms
Clinical Laboratory Improvement Amendments (CLIA) laboratories
Combination products
Cosmetics
Dietary supplements
Drugs and generics
General wellness products
Healthtech and digital health
In-vitro diagnostics
Research Use Only (RUO) products
Medical devices
Patient engagement tools and platforms
Software as a medical device (SaMD)

The firm’s multidisciplinary team has practical experience in representing clients in regulatory FDA matters, including:

Advertising and promotional review
Compassionate use or expanded access requirements
Citizen petitions
Go-to-market strategy and business model review
IDE, 510(k), De Novo, and PMA requirements
IND, NDA, BLA, and ANDA requirements
FDA compliance and enforcement
FDA designation programs
FDA regulation of clinical trials
FDA regulatory exclusivities
FDA regulatory risk mitigation strategies
Orange Book listing
Patent Term Restoration/Patent Term Extension
Preparation for commercial launch, including manufacturer healthcare compliance programs
Regulatory review of various contracts, including clinical trial agreements, supplier/contract manufacturer contracts, license agreements, and other commercial contracts
Regulatory review of public disclosures
Regulatory due diligence during corporate transactions, including financings, M&As, asset sales, and IPOs
Strategies for expediting FDA review and approval
Trade complaints to the FDA
Transfer, sale, or change of ownership for FDA submissions/filings

Overview

Our attorneys advise companies across the full spectrum of FDA-regulated products and industries, including:

Biologics and biosimilars
Cell, tissue, and gene therapies
Clinical decision support products and platforms
Clinical Laboratory Improvement Amendments (CLIA) laboratories
Combination products
Cosmetics
Dietary supplements
Drugs and generics
General wellness products
Healthtech and digital health
In-vitro diagnostics
Research Use Only (RUO) products
Medical devices
Patient engagement tools and platforms
Software as a medical device (SaMD)

The firm’s multidisciplinary team has practical experience in representing clients in regulatory FDA matters, including:

Advertising and promotional review
Compassionate use or expanded access requirements
Citizen petitions
Go-to-market strategy and business model review
IDE, 510(k), De Novo, and PMA requirements
IND, NDA, BLA, and ANDA requirements
FDA compliance and enforcement
FDA designation programs
FDA regulation of clinical trials
FDA regulatory exclusivities
FDA regulatory risk mitigation strategies
Orange Book listing
Patent Term Restoration/Patent Term Extension
Preparation for commercial launch, including manufacturer healthcare compliance programs
Regulatory review of various contracts, including clinical trial agreements, supplier/contract manufacturer contracts, license agreements, and other commercial contracts
Regulatory review of public disclosures
Regulatory due diligence during corporate transactions, including financings, M&As, asset sales, and IPOs
Strategies for expediting FDA review and approval
Trade complaints to the FDA
Transfer, sale, or change of ownership for FDA submissions/filings

Eva F. Yin

Partner

Seattle

Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.

Regulatory

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Ty Kayam

Of Counsel

Seattle

Ty Kayam is Of Counsel in the Seattle office of Wilson Sonsini Goodrich & Rosati. She advises companies and investors on regulatory strategy for health technology products, especially where legal risk depends on product architecture, data use, and clinical context. Her practice focuses on health AI, digital health, health data infrastructure, connected and wearable devices, and medical robotics.

Regulatory

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Daniel E. Orr

Senior Counsel

Dan Orr is senior counsel at Wilson Sonsini Goodrich & Rosati, where he brings an insider’s perspective to helping clients prevent and solve problems with the U.S. Food & Drug Administration. Dan, a former FDA regulatory counsel, has more than 20 years of experience concerning regulation of drugs, biologics, and medical devices.