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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze