Pharmaceutical Executive-05-01-2004

Last year, FDA released a series of concept papers that summarized the agency's plans for risk management. One described a new mandate for the pharmaceutical industry: to develop a risk management plan (RMP) for each drug, to be submitted to FDA at the time of the new drug application. The concept papers still need to be finalized and converted into a guidance (a document that explains how companies may comply with FDA regulations), but the mandate is likely to go into effect this year.

College isn't just for students anymore. It's for companies too. Over the past decade, institutions of higher education have increasingly found that some of their most important stakeholders are their students' employers?and that they can extend their reach and influence by responding to the needs of local and regional business.

How well is the pharma industry prepared for rapidly approaching industry upheavals? Not very, according to a 2002 global survey on corporate early warning systems conducted by the Fuld-Gilad-Herring Academy of Competitive Intelligence. More than 100 managers responded, most of whom work in their companies' strategy, product management, or intelligence departments.

May 2004 Table of Contents