Category Archives: FDA Policy

A (Slight) Liberalization of Communications with Docs from FDA

What Happened. This week FDA issued a new final guidance related to communications about medical products that, while representing a slight liberalization of regulation when it comes to discussing useful information about a drug and the cleared uses for it, … Continue reading

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The Back and Forth on Safety Versus Speed and FDA

This week the Commissioner issued a statement related to the proposed modernization of the FDA’s drug review office, also the subject of a blog post by FDA’s head of the Center for Drug Evaluation and Research Janet Woodcock. While focused … Continue reading

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FDA and The Scarlet Letter

FDA apparently intends to implement today an idea that has been kicking around for a while to begin publishing the names of companies that have had letters of complaint lodged against them asserting that they are taking actions to block … Continue reading

Posted in FDA Policy, Generic Drugs | 1 Comment

Treating the Patient, Not the Symptoms – FDA and Digital Health

Last week Commissioner Scott Gottlieb delivered remarks at the Health Datapalooza, the meeting representing a nexus between innovation in digital health and the world of policy. He began his talk by saying that for most of the last century, medical … Continue reading

Posted in FDA Image, FDA Policy, Medical Devices | 1 Comment

FDA Enforcement Lags, Focus on Promotion of Unapproved Drugs

It goes without saying that enforcement by FDA’s Office of Prescription Drug Promotion (OPDP) as identified through regulatory action letters (warning or untitled) over the past few years is a mere shadow of its former self. Enforcement was once robust, … Continue reading

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