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:
- FDA Overhauls its Draft Guidance on Clinical Decision Support (“CDS”) Software
- FDA CBD Roundup: Agency Continues Existing Enforcement Approach While Reviewing Public Comments and Considering Future Policy Approaches
- A Guide to FCA Cooperation Credit for Life Sciences Companies
- Supreme Court Clarifies That Judges, Not Juries, Must Determine Whether FDA Actions Preempt State Failure-to-Warn Claims Against Drug Manufacturers
- New FDA Draft Guidance on Voluntary Recalls Asks: Are You Prepared?
- Federal Circuit Affirms ITC’s Non-Institution Decision, Offering Guidance for Future FDCA-Related Section 337 Claims
- Aiming to Foster Innovation, FDA Proposes Regulatory Framework Specific to Prescription Drug Software
- Another Step Toward Harmonization: FDA Issues Proposed Rule to Waive Informed Consent Requirements in Minimal-Risk Studies
- FDA Issues Final Guidance Documents Relating to Medical Product Manufacturer Communications
- FDA Issues Draft Guidance on Devices with Multiple Functions
- 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