February 28, 2006
Over the course of the next several days, I’m going to be writing on the many ways in which the new regulatory era is going to affect business as usual for bringing new products to market. Lesson 1 – The … Continue reading →
February 27, 2006
For those working in or around the pharmaceutical or biologics industry, it is understood that the issues a product faces in coming to market are not confined to the FDA. In other words, while the FDA focus is strictly on … Continue reading →
February 24, 2006
Are drugs suddenly riskier or is the FDA suddenly more vigilant? Questions about the agency’s efficacy in protecting public health began to increase a few years back, when the ephedra issue presented itself and many critics thought that the agency … Continue reading →
February 23, 2006
According to FDA regulations, one cannot state a claim that one’s drug or biologic is superior to another unless there has been a head to head study demonstrating that superiority. That regulatory reality can be frustrating to communications professionals who … Continue reading →
February 22, 2006
During the past two years, the FDA has been repeatedly questioned in very public ways as to whether or not it is acting to protect public health. A consequence of that fact is that the agency must appear ever vigilant … Continue reading →