Category Archives: FDA Image

Is FDA Set for Another Banner Year of Approvals?

In 2015, FDA experienced a banner year with respect to the number of novel drugs and biologics that were approved by the agency – 45 all told. Since then, the 21st Century Cures Act was passed with the goal, among … Continue reading

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New FDA Directions, Part 1 – Pricing

With a change in leadership at FDA there naturally a great deal of anticipation with regard to the potential for new direction for the agency and the impact it will have on the agency’s diverse stakeholders. That is especially true … Continue reading

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FDA and Patient Involvement

“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading

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What They Said – 2nd Quarter 2017

During a somewhat slow week given the holiday that coincides with the end of the second quarter, this is a good time to look back at press releases for the quarter and the year so far. A single press release … Continue reading

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What Do Patients Want?

Thirty years ago, HIV advocates elevated the notion of patient involvement in the development of new medicines to entirely unprecedented levels by demanding input into multiple aspects of clinical development of HIV treatments.  That included not only in the way … Continue reading

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