Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret an

FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulation

This guidance will assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors o

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise

The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first e