Tag Archives: #FDA

The Year in AdComms – A Look Back at 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Now, with no more … Continue reading

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FDA’s OPDP Issues Third Letter of 2023

For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came … Continue reading

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What They Said – Reviewing the First 6-Months of FDA Communications

Every six months, we do a look-back to see what has changed in the way that FDA is communicating. One might not think there is much difference over time, but there is. For example, the air has pretty much gone … Continue reading

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What They Said – Looking Back at FDA Press Releases During 2022

Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are … Continue reading

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When the Going Gets Tough – FDA AdComms in 2022

Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. The mechanism provides an open … Continue reading

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