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What They Said 2021 – An Overview of FDA Press Statements
Each year we look back to take stock of how the agency has been communicating in the course of the previous year and assess how that might compare to years gone by. In fact from year to year, there is...
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OPDP Issues First Regulatory Action Letter of 2022
FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by...
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Are We Moving On From Covid?
Mask mandates are dropping like flies. Restrictions are being lowered. In my observation, it feels that they are going to the wayside not only because of dropping caseloads, but also because people...
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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...
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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...
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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...
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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...
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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...
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FDA’s OPDP Sends First Regulatory Letter of the Year Aimed at Rx Drug Promotion
Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency...
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What They Said – FDA Press Releases in 2023
Less is more? Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. One might not think that a large agency would vary...
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