Category Archives: Regulatory Communications

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

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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

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Common Sense Confirmed

Common Sense Confirmed – Study Reveals Talking to the FDA is Good! – From the department of Dog Bites Man, the FDA issued a press release on February 9 revealing that pharmaceutical and biotech companies that communicate more frequently and earlier … Continue reading

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