Charles J. Raubicheck, one of the country’s foremost Food and Drug attorneys, is a partner at Frommer Lawrence & Haug and heads the firm’s FDA/Regulatory practice.
Mr. Raubicheck began his career as a lawyer for the U.S. Food and Drug Administration from 1971-1975, handling a wide variety of litigation and administrative law matters. For the past 32 years, he has been engaged in private legal practice in the FDA and related areas of law. He is an authority on pharmaceutical regulatory issues, with a focus on representing drug companies in matters before the FDA, and in cases before the federal courts.
Mr. Raubicheck also has significant experience in FDA regulatory matters involving foods, dietary supplements, cosmetics, medical devices, and biological products. In addition, he maintains an active trademark and advertising law practice for companies in FDA-regulated industries.
Mr. Raubicheck has taught Food and Drug law for 30 years at New York University School of Law and is a widely published author in the field. He twice served as Chair of the New York State Bar Association in the Food, Drug, and Cosmetic Law sector. He is also a frequent speaker on FDA-related topics.
Charles Raubicheck has been listed in the New York Super Lawyers 2007 Metro Edition.
PUBLICATIONS
- Best Practices for Food and Drug Law, Aspertore Books (2005), Chapter: “Advising and Representing Regulated Companies.”
- Marketing Dietary Supplements (with I. Scott Bass), The Food and Drug Law Institute, 1st Edition (2000).
- DSHEA’s Third-Party Literature Exemption: Mail Order Sales, Direct Marketing, and Internet Use, Food and Drug Law Journal (FD Law J.) 54: 587-593 (September, 1999).
- Landmark FDA Regulations on Fruit and Vegetable Juice Labeling, FD Law J. 47: 163-166 (March, 1992).
- The FDA’s Implementation of the Safe Medical Devices Act of 1990, Food, Drug Cosmetic Law Journal (FDC Law J.) 46: 885-890 (November, 1991).
- FDA Enforcement of the Nutrition Labeling and Education Act (with Leslye B. Davidson), National Law Journal, June 17, 1991.
- Labeling a Medical Food, FDC Law J. 44: 533-536 (September, 1989).
- FDA’s Primary Jurisdiction in New Drug Enforcement: Meaningful Reforms, FDC Law J. 37: 232-236 (June, 1982).
- The OTC Drug Review – A Change in Direction, FDC Law J. 35: 179-184 (March, 1980).
- How to Comply with the New Medical Device Law (with William F. Weigel), FDC Law J. 31: 312-326 (June, 1976).
SPEAKING ENGAGEMENTS
- ACI Conference on Maximizing Pharmaceutical Patent Life Cycles, San Francisco, June 12-13, 2006: "Drugs and Biologics: The Regulatory Approval Process" and "Updated Guidelines for Paragraph IV Certification Notice Letters"
- ACI Conference on Maximizing Pharmaceutical Patent Life Cycles, New York, October 24, 2006: " Present Controversies and Uncertainties in Market Exclusivity"