A clear understanding of FDA regulatory requirements is essential to the success of a life sciences company. Our Washington, D.C.-based FDA regulatory team includes seasoned lawyers knowledgeable in all areas of FDA regulation. The team’s varied backgrounds bring a breadth of perspectives to the practice which includes attorneys who have worked at the FDA, as in-house counsel at life sciences companies and as key policy advisors in Congress.
Our clients include many of the world’s leading pharmaceutical and biologics companies, medical device manufacturers and cosmetics, food and dietary supplement companies and distributors. We offer comprehensive services, including:
- Regulatory Strategy, Product Development & Product Approvals
- Advertising & Promotion
- Post-Approval Compliance
- FDA Enforcement Actions & Litigation
- Congressional Investigations & Public Policy
- Due Diligence Reviews & Transactional Support
As part of our multidisciplinary life sciences group, our FDA regulatory team has a broad view of the commercial and regulatory forces affecting life sciences companies. In addition to traditional regulatory counseling and administrative litigation, we advise clients on corporate and transactional matters, government enforcement investigations, compliance program design and implementation, and FDA-related intellectual property analyses and litigation.
We also provide counseling to clients regarding other related government agencies, including the Federal Trade Commission (FTC), Consumer Product Safety Commission (CSPC) and the U.S. Department of Agriculture (USDA). Our advertising practice also includes representation of clients subject to challenges brought before the National Advertising Division of the Better Business Bureau (NAD). For more information about our services, please contact one of our FDA attorneys.
Our FDA attorneys have extensive knowledge and experience across various industries and segments within the life sciences industry. Our practice provides regulatory services for the following areas:
- HHS Reverses Course on LDTs: COVID-19 LDTs Again Require FDA Premarket Review
- CMS Finalizes Repeal of Medicare “Breakthrough” Device Coverage Rule, Pledges to Invite Further Industry Input
- A Question of Intent: FDA Amends Intended Use Regulations with Goal to Provide More Clarity, But Significant Questions Remain
- The Supreme Court’s Decision in AMG Capital Management V. FTC – What Does It Mean for FDA Enforcement?
- New Laws Narrow the Scope of Market Exclusivity and Seek to Increase Awareness of Biosimilars
- Non-Binding Guidance: Recent Developments in FDA Inspection Policy and Implications For Drug and Device Manufacturers
- Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule
- Decoding Digital Health: Recent Developments in AI and Machine Learning for Life Sciences and Health Care
- Non-binding Guidance: FDA’s Intended Use Final Rule
- Non-binding Guidance: COVID-19 Vaccine Mandate Litigation
- Decoding Digital Health: 2021 Developing Trends and Hot Topics in Digital Health
- Non-binding Guidance: The Defense Production Act and the COVID-19 Pandemic
- Non-binding Guidance: European Life Sciences Regulatory Trends with Dr. Lincoln Tsang
- Non-binding Guidance: FDA Regulatory Developments in AI and Machine Learning
- 2020 Enforcement Review: FDA-Regulated Medical Products and Food Safety
- 2019 FDA Enforcement Review: Drugs, Biologics, Devices, and Dietary Supplements
- DOJ’s Granston Memo and Recent Government-Requested Dismissal of False Claims Act Case Have Significant Implications for FDA-Regulated Entities
- A Guide to FCA Cooperation Credit for Life Sciences Companies
- A Closer Look At CMS' Drug Price Disclosure Proposal