FDA

Mintz Levin’s FDA practice group provides regulatory and strategic advice to clients regulated by the U.S. Food and Drug Administration.  Our pharmaceutical, biotech, medical device, cosmetic and dietary supplement clients range in size from small start-ups to established Fortune 500 companies, foreign manufacturers, and trade associations.  We are also counsel to investment banks and venture capital companies in connection with public and private stock offerings and mergers and acquisitions involving FDA-regulated companies.  Whatever our clients' size, we listen carefully and leverage our experience to assist them in a cost-effective manner.  We provide guidance to clients through the preclinical development and clinical development phases of product development to product approval, product launch and the myriad of postmarketing obligations.  Enlisting the assistance of our intellectual property, corporate and licensing, securities, health, reimbursement, anti-trust, tax and litigation colleagues, we provide integrated, practical advice for successful product development and marketing. 

Our experience includes:

• Representing clients on compliance and enforcement actions before the FDA, Federal Trade Commission (FTC), Drug Enforcement Administration (DEA), U.S. Department of Justice and state attorneys general.
• Assisting with all aspects of clinical trials, including clinical trial agreements, arrangements with contract research monitors (CROs) and other service providers.
• Counseling clients on research involving human cellular and tissue-based products.
• Advising clients developing clinical laboratory tests on regulatory, licensure and marketing issues.
• Providing regulatory and reimbursement due diligence on a wide variety of drug and medical device companies.
• Obtaining de novo reclassification on behalf of a medical device company.
• Assisting clients in responding to FDA inspections (483s), Warning Letters and other compliance-related communications.
• Assisting clients in determining approval pathways, including those for combination products.
• Advising clients on labeling, advertising and promotional issues.
• Advising clients on the content of press releases announcing regulatory and clinical developments and on disclosures in SEC-required filings.