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, clinical research, food and dietary supplement, medical device, animal, and cosmetic industries. The group also has extensive experience with regulation of the food industry conducted by the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS), as well as the requirements of other USDA agencies. Our team members include attorneys who have worked at the FDA, Federal Trade Commission (FTC), USDA, 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); and assistance with responding to FTC Civil Investigative Demands (CIDs);
  • Product development and approval strategies (Premarket Approval Applications and Premarket Submissions in the pharmaceutical, medical device, and food space including new and abbreviated new drug applications and investigational new drug applications, medical submissions, such as Section 510(k) premarket notifications, de novo classification requests, IDE submissions, and humanitarian device exemption (HDE) submissions, and food-related submissions, including GRAS, new dietary ingredient and food contact notifications, and food additive petitions);
  • Recalls (assisting companies that manufacture and distribute FDA and USDA-regulated products throughout the recall process);
  • Labeling, promotion, and advertising compliance and enforcement (FDA and FTC regulation for prescription (Rx) and over-the-counter (OTC) drugs, foods and dietary supplements, cosmetics, and medical devices
  • 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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