Overview

Wiley’s Food & Drug Practice has the depth of experience and breadth of resources to effectively handle complex legal and regulatory challenges, as well as the more routine but crucial regulatory tasks required of U.S. Food and Drug Administration (FDA)-regulated companies in the pharmaceutical, biotechnology, food, and dietary supplement industries. Our team members include attorneys who have worked at the FDA, Federal Trade Commission (FTC), and as in-house counsel at large consumer product companies, and who have received independent recognition from numerous organizations as leaders in food and drug law.

We offer comprehensive services in the following broad areas:

  • Regulatory compliance (assistance with appropriate responses to FDA Form 483s, Warning Letters, Untitled Letters, Import Detentions and Alerts, Application Policy Letters, Clinical Investigator Disqualification proceedings, and Clinical Hold Letters);
  • Product development and approval strategies (Premarket Approval Applications and Premarket Submissions, including GRAS Notifications and Food Contact Notifications for the marketing of a range of regulated products, including novel food ingredients, food packaging materials and biotech products);
  • Recalls (assisting companies that manufacture and distribute FDA-regulated products throughout the recall process);
  • Promotion and advertising compliance and enforcement (FDA and FTC regulation for prescription (Rx) and over-the-counter (OTC) drugs, foods, and dietary supplements, and assistance with responding to FTC Civil Investigative Demands (CIDs);
  • Due diligence and transactional support involving FDA regulatory issues (mergers & acquisitions, product acquisitions, licensing agreements, joint ventures, initial public offerings (IPOs), venture funding);
  • Administrative advocacy and litigation before agencies and the courts (FDA meetings, administrative appeals, citizen petitions, Administrative Procedure Act (APA) litigation);
  • Competitive regulatory strategies (lifecycle management, Hatch-Waxman patent litigation support); and
  • Enforcement and white-collar defense.
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