Category Archives: FDA Policy

More or Less – A Look at FDA Press Releases at Half Year

What do FDA press releases for the year say about the rate of new approvals for 2016? Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I … Continue reading

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More or Less – FDA Press Releases 1st Quarter 2016

There are going to be times when FDA has less to say than at other times. In fact, there have actually been times where the agency has gone weeks without issuing a press release about anything. This quarter was not … Continue reading

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Patient Engagement Mainstreams

One Tuesday morning early in October in 1988, a large group of protestors appeared in front of the building that housed the Food and Drug Administration and effectively shut the agency down. There were hundreds of protesters present, organized by … Continue reading

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Testimonials – The Pitfalls

People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals. Pew Research has shown that especially for … Continue reading

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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

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