Category Archives: FDA Policy

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

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

FDA Guidance Output Plans for 2016

While there has been focus on what FDA accomplished in 2015 – and there will continue to be some of that – it is also a great time to look ahead. What can we anticipate for 2016? This month several … Continue reading

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