Increased scrutiny by the U.S. Food & Drug Administration of the biological, food, medical device, pharmaceutical and tobacco industries has made skilled legal counsel essential for clients on compliance and regulatory matters and risk mitigation.

At Fox Rothschild, we help clients effectively address FDA concerns and anticipate hurdles that may arise as they strive to grow and expand their businesses. We provide strategic counseling on product formulation, regulatory approval, labeling, good manufacturing practices, claim substantiation, recall issues and other matters across FDA product centers. We also help clients successfully navigate the complicated intersection of regulations promulgated by the Federal Trade Commission and the FDA, particularly in connection with advertising and product dissemination.

Our team of attorneys has a deep understanding of the statutes and regulations under which the FDA operates, gained from previous experiences as in-house general counsel, chief compliance officer and other senior executive positions, as well as serving as lead outside counsel for regulatory and litigation matters for dietary supplement, medical device, pharmaceutical and tobacco companies and industry trade associations. Fox attorneys are also active in the renowned Food and Drug Law Institute, serving on its Academics Programs Committee and Policy Forum Editorial Advisory Board.

Regulatory Compliance

For both private and public companies, we offer guidance on regulatory compliance throughout the product life cycle, from development and approval/clearance to advertising, marketing and distribution.

Our services include:

  • Providing strategic advice to senior management on new FDA rules
  • Proactively petitioning the FDA, on behalf of clients, to alter regulations
  • Advising on FDA compliance related to Quality System Regulations (QSR) and Current Good Manufacturing Practice (cGMP)
  • Counseling on the new Food Safety Modernization Act (FSMA), food labeling and consumer fraud
  • Assisting in the development, implementation and operation of targeted compliance tracking systems and business programs, including FDA QSR/cGMP employee and internal auditor training
  • Providing clinical trial development and oversight, including drafting and negotiating multisite collaborative clinical trial agreements
  • Preparing and submitting applications, including 510(k)/PMA/DMF, Abbreviated New Drug Application (ANDA), New Drug Application (NDA) and Drug Master File (DMF) submission services
  • Reviewing product promotional materials to ensure compliance – from labeling to advertising and beyond
  • Advising on company strategies to help minimize risk related to product liability, antitrust and corporate compliance
  • Conducting training on the False Claims Act, anti-kickback statutes, Health Insurance Portability and Accountability Act (HIPAA), Stark laws and Medicare and Medicaid conditions of participation

Crisis Intervention and Litigation Services

We offer assistance with:

  • FDA audits and enforcement
  • Internal corporate audits and investigations to manage and mitigate risk
  • Government inspections
  • Preparing replies to FDA 483 and warning letters
  • Implementing corrective action or product recall
  • Undergoing a clinical trial investigation
  • Medical Device Reporting (MDR) filing
  • Recall litigation and counseling
  • Consumer fraud and labeling litigation