Eye on FDA | RX for Pharma Industry Communications and Planning
Eye On FDA. There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact...
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Virtual Reality – FDA and AdComms | Eye on FDA
Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the conseque...
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Eye on FDA | RX for Pharma Industry Communications and Planning
There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new molecular e...
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Crisis Communications and FDA | Eye on FDA
In the face of a crisis situation, it is a given that the clarity and thoroughness of the communications response is key to resolving the issue and mitigating any reputational damage. Perhaps no othe...
Eyeonfda.com news digest
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1 month
FDA Adds New AdComm to Address Genetic Metabolic Diseases
Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). As noted in a recent posting here, last year saw...
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2 months
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 much in terms of volume or style from year to year, but that is not... -
3 months
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 to Novartis in relation to promotional content regarding...
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4 months
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 AdComms scheduled...
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| Web host: | Google LLC |
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| Updated: | January 22, 2023 |
| Expires: | January 27, 2024 |
| Created: | January 26, 2006 |
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