Food, Drug & Cosmetic Law Section

FDA Resources

• FDA
• FDA’s Electronic Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
• [email protected]
• Biologics Products and Establishments
• Recently-Approved Devices
• Animal [email protected]
• FDA inspections, Compliance, Enforcement and Criminal Investigations
• FDA Docket Notice (www.regulations.gov)
• ClinicalTrials.gov
• Purple Book (approved human biologics)
• Green Book (approved animal drugs)
• Medical Device Approvals (PMAs)
• Medical Device 510(k)s

USDA Resources

• U.S. Department of Agriculture
• Biotechnology Regulatory Services
• Veterinary Biologics

International Regulatory Authorities

• European Medicines Agency
• European Union Clinical Trials Register
• Medicines and Health Care Products Regulatory Agency (United Kingdom)
• Health Canada
• Pharmaceuticals and Medical Devices Agency, Japan

Section History

The New York State Bar Association (NYSBA) established the Food, Drug and Cosmetic Law Section in 1945 as one of the first sections of the NYSBA.

The Food, Drug and Cosmetic Law Section was formed in 1945 following enactment of the Food, Drug and Cosmetic Act of 1938 (“the Act”).  This NYSBA section was the first of its kind in the nation, serving as the forum for those experts in this field in the private and public sectors.  The Chair cited the importance of the increasing the bar’s knowledge of the Act, the work of the Food and Drug Administration, the intended consumer benefits, and the enhancement of technical and ethical standards of industries involved.

“The action of the Association, setting up a Section on Food, Drug and Cosmetic Law, is worthy of special notice not only as this is the first Section of its kind, but also because it will tend to give this branch of law the prestige, the dignity, and the attention which it so clearly merits.”  – Charles Wesley Dunn, first Chair, on the creation of the Section.

In addition to food, drug, and cosmetic issues, committees were also created on related fields of practice.  Within several years of creation, the Section successfully urged creation of a Food and Drug Committee within the Administrative Law Section of the American Bar Association.  Over the years, the Food, Drug and Cosmetic Law Section’s committees have evolved to meet the times.

In its first year, the Section began professional education programs continued today on legislative and administrative developments, ramifications of amendments to the Act, enforcement procedures, approval and marketing in interstate commerce, advertising compliance, and product liability issues.  The focal point for the Section’s professional education has always remained the NYSBA’s Annual Meeting, supplemented with specialty topics and events throughout the year.