Category Archives: Regulatory Communications

Promotion of Investigational Compound – Historical Overview

Communications regarding medicines in development – often referred to as “investigational compounds” can be particularly challenging. On the one hand, there are data milestones and advancements for the product through the regulatory cycle about which there is great interest. On … Continue reading

Posted in FDA Policy, Regulatory Communications, Warning Letters | 1 Comment

A Serial on Cereal – The FDA and the FTC

In May of last year, the Food and Drug Administration sent a Warning Letter to General Mills about a box of Cheerios.   The problem?  The FDA read the Cheerios box and didn't like what they saw when it came … Continue reading

Posted in Food, Regulatory Communications | Comments Off

A Bitter Pill to Swallow – The Perils in Off Label Promotion

On September 29, the US. Attorney's Office for the Northern District of California announced that a former CEO of InterMune was convicted of wire fraud for the "creation and dissemination of false and misleading information about the efficacy of InterMune's … Continue reading

Posted in Regulatory Communications | 3 Comments

Social Media and Pharmaceutical Marketing

On several occasions in the past, I have posted here on the need for pharmaceutical companies to embrace new and social media, along with several suggestions for doing so. One of the perceived barriers to the involvement of pharmaceutical companies, … Continue reading

Posted in Marketing, Regulatory Communications, Social Media, Useful Resources | Comments Off

Anatomy of a Consent Decree

Following yesterday’s posting about catching up, another thing that happened last week is that a Consent Decree was issued by the FDA.  The company involved was Shelhigh, Inc., which produces implantable devices. First of all, what is a Consent Decree?  … Continue reading

Posted in Crisis Communications, Current Affairs, Regulatory Communications | 3 Comments