Talks & Articles -- Archives

About the Archives

My Archives consist of the vast majority of my past presentations and articles and are made available as a resource for you on the wide variety of FDA legal topics I have addressed over the years.  The presentations and articles are grouped by topic and within each topic are listed in chronological order with the most recent first.  For the vast majority of these items, the actual presentation or article is accessible by the clicking on the title of the presentation or article (if title is underlined, bold & italics, there is an active link).

Advertising & Promotion

Clinical Research

Combination Products

Compliance & Enforcement

Crisis Management

Dietary Supplements & Functional Foods

Drugs & Biologics

Food & Food Additives

Generic Drugs & Biosimilars

Import/Export & Harmonization

Medical Devices, IVDs, & Digital Health

OTC Drugs & Cosmetics

Outsourcing & Contracting

Product LifeCycle Strategy

Veterinary Medicine