Category Archives: Regulatory Communications

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

Tracking Approvable Letters

There are three general outcomes from submitting a new drug to the FDA for approval.  First – approval, for which everyone hopes.  Second non-approval, which is the obvious bad scenario.  Third are approvable letters, issued by the FDA when they … Continue reading

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Warning About Warnings!

As I mentioned in an earlier posting on February 24, the FDA has dramatically increased the issuance of MedWatch Alerts.  Now the Baltimore Sun reports on the issue, which touches upon another matter discussed here – the relevance of FDA … Continue reading

Posted in FDA Policy, Regulatory Communications, Risk Management | Comments Off on Warning About Warnings!

Lessons for a New Regulatory Era, Part 2

Risk management is an iterative process, as the FDA likes to say. There are a broad spectrum of activities that comprise efforts at managing risk. There is the product labeling and within that there is the Black Box Warning (see … Continue reading

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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