It is always great to see a new edition of Fundamentals of US Regulatory Affairs, the flagship guide to how drugs, biologics and medical devices are regulated in the US. The regulatory landscape constantly changes, with new policies, guidances and regulations appearing every year. RAPS has responded to these changes by updating Fundamentals every few years; as a result, it is an essential tool for all regulatory work. All of us who work in regulatory welcome each new edition.
This book is comprehensive. Thirty-eight chapters cover every possible US regulatory topic, including US Food and Drug Administration (FDA) history, regulatory pathways, Good Laboratory Practices, Good Clinical Practice, Good Manufacturing Practice, prescription drug (including generic drug) submissions and compliance, over-the-counter drugs, medical device submissions and compliance, in vitro diagnostics submissions and compliance, biologics submissions and compliance, advertising and labeling, combination products, drugs for pediatrics, blood products, cell and tissue products, dietary supplements, cosmetics, veterinary products and food products. Several new topics have been added to this edition as chapters, including companion diagnostics, medical foods, crisis management, health technology assessment and pharmacovigilance.
One of these new chapters, "Companion Diagnostics," is clear, thorough and beautifully written, addressing a regulatory area that has become important only in recent years. As the number of such products has increased, FDA has responded to the need for a new regulatory framework. FDA has defined a companion diagnostic as a very specific type of product: "an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product." This definition deliberately excludes those in vitro diagnostic tests that might help a physician decide whom to treat but where the safe and effective use of the drug is not dependent on the result of the diagnostic test. In addition to the policy outlined in FDA's 2011 draft guidance on companion diagnostics, the agency also has developed policy by creating precedents. As described in this chapter, there are recent cases in which FDA has either designated existing FDA-approved diagnostic tests as companion diagnostics or explicitly stated that existing diagnostic tests did not constitute suitable companion diagnostic tests at the time the drug for the disease was approved.
Another new topic is the unusual chapter on "Medical Foods," i.e., products intended for "the specific dietary management of a disease or condition," and which must be intended for use under medical supervision. Prior to 1972, FDA regulated these products as drugs; after that they were regulated as foods, but a special category of food with very different labeling requirements from those for ordinary foods. They were designated as "foods for special dietary use" until around 1997 when the term "medical foods" was introduced.
I was particularly interested in the chapter on Prescription Drug Labeling, Advertising and Promotion. Issues of drug advertising tend to arise at unexpected times, and it is valuable for regulatory professionals to know FDA's requirements. For instance, there are different requirements for submission of proposed drug advertising for new drugs approved under Accelerated Approval (promotional material must be submitted 30 days before use) than for all other drugs (submission at the time of dissemination required, but advance submission often done voluntarily). By tradition, television advertisements usually are sent to FDA for approval before they are used, although this is not required. Internet promotion is closely watched by FDA, but no guidance documents have been issued yet either for Internet promotion or social media promotion; information on what FDA expects is often obtained by analyzing the "Enforcement Actions" that are posted in detail on the FDA website and often include copies of the violative material.
This book is an outstanding overview of the drug, biologic and device regulatory pathways and requirements. It is thorough and clearly written. Not only is it useful for anyone who wants to learn about the regulatory process; it also provides a ready reference for experienced regulatory professionals.
Editor's note: Fundamentals of US Regulatory Affairs, Eighth Edition is available from the RAPS Store both in print and as an e-book for $249.95 with free shipping for RAPS members or $309.95, plus shipping, for nonmembers.