Overview
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.
Industries Served
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:
Insights
- Federal District Court Holds Clinical Trial Sponsors Must Submit More Data to ClinicalTrials.Gov
- FDA and FTC Announce Collaboration to Promote Biosimilar Competition; FDA Issues Draft Promotional Guidance
- FDA Issues Gene Therapy Guidances
- One Step Toward Clarity: USDA Issues Interim Final Rule Establishing Hemp Production Program
- FDA Overhauls its Draft Guidance on Clinical Decision Support (“CDS”) Software
- Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
- Non-binding Guidance: A Discussion of Kisor v. Wilkie
- Non-binding Guidance: Breakthrough Devices Program
- Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
- Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
- Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
- Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
- Non-binding Guidance: FDA’s Regulation of Products Containing CBD
- Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
- 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
- FDA Clarifies Communication Rules for Medical Product Companies
- Lessons From FDA Draft Guidance On Multifunctional Devices