Tag Archives: FDA

Sorting it Out – FDA AdComm Review for 2018

In 2017, the Advisory Committees voted to recommend approval 71.4 percent of the time; in 2018 it was 66.6 percent. Continue reading

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Happy New Year – and FDA Statement on Government Shutdown

Happy New Year. On a personal note, I have been on a hiatus or shutdown myself to take time while undertaking a move. With that behind me, I am back at it and will be posting again with intermittent content … Continue reading

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HHS Proposes Pricing in DTC

In May the Administration released a plan called “America’s Patients First” , a blueprint to lower drug prices and reduce out-of-pocket costs. One of the items contained in that blueprint was to have the manufacturers of medicines include the list … Continue reading

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Pre-Game Show – What Some of the Important Players Have to Say at the FDA Part 15 Meeting on Social Media

This week a large number of people and entities released their presentations that will be given at the FDA Part 15 Meeting on Social Media and Medical Product Promotion to be held Thursday and Friday, November 12 and 13th at … Continue reading

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