FDA Regulatory
Sidley has an internationally recognized food and drug practice, representing major pharmaceutical, biological, medical device and food clients all over the world relating to the development, manufacture and marketing of products regulated by the Food and Drug Administration (FDA), the European Commission, the European Medicines Agency (EMEA) and other related government authorities.
Sidley’s extensive experience is well recognized in the industry. Sidley lawyers serve as instructors for drug law courses provided to FDA. We also chair the annual advertising and promotion meeting of the Food and Drug Law Institute (FDLI), the annual advertising and promotion and pricing meetings for the American Conference Institute (ACI) and the ACI FDA boot camp for intellectual property and products liability lawyers.
Our group includes former federal prosecutors – including one who was in charge of FDA’s special prosecution task force – and a former member of the European Commission’s Legal Service with responsibility for review of all food and drug related proposals. Our group also has a U.S. Medical Doctor, an EU physician and a Ph.D. geneticist.
Our client base is diverse, but united by a common thread: a commitment to creative and pragmatic engagement with FDA and other governmental regulatory agencies. Our clients operate in a heavily regulated industry and face the scrutiny of government regulators and prosecutors. We assist our clients in creatively and successfully addressing government concerns.
Our food and drug practice runs the entire gamut from
Regulatory to
Good Manufacturing Practice (GMP),
Enforcement to
Compliance.
