Monthly Archives: February 2006

Lessons for a New Regulatory Era

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

Posted in Advisory Committee Prepapartion | Comments Off

A Resource on Reimbursement – The Piper Report

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

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Alert on MedWatch Alerts!

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

Posted in Risk Management | Comments Off

Class of One – Avoiding Warning Letters, Part II

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

Posted in Regulatory Communications, Warning Letters | 1 Comment

Sales and Warnings

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

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