FDA Regulations On Drug Promotion

A "book unlike any other" is one way that Understanding Food and Drug Administration Regulations on Drug Promotion has been described. The book is a 250-page review of all aspects of promoting drugs and biologics, and can be used as a training manual for marketing, regulatory affairs and medical staff, according to Guildford Press, which is promoting it.

The book, which is written by Nigel Rulewski, attempts to interpret and analyse what the US FDA requires in relation to drug promotion. This includes:

FDA requirements for labeling, promotional labeling and advertisements; the legal basis of FDA control of promotional materials; the use of the brief summary; promotional content; comparative claims; generic advertising; biologics; pre-approval advertisements; advertising investigational products; use of internal reviews; working with the media; direct to consumer advertising; planning scientific and educational meetings; use of press materials; gifts to physicians; FDA enforcement options; and legal implications of promotional activities.