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 (...
http://eyeonfda.com/2024/03/fda-adds-new-adcomm-to-address-genetic-metabolic-diseases/
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 … Conti...
http://eyeonfda.com/2024/02/what-they-said-fda-press-releases-in-2023/
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 t...
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 change...
http://eyeonfda.com/2023/12/the-year-in-adcomms-a-look-back-at-2023/
While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters...
http://eyeonfda.com/2023/11/fdas-opdp-issues-two-new-untitled-letters/
FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital h...
http://eyeonfda.com/2023/10/fda-launching-new-advisory-committee-on-digital-health/
FDA has announced that the Office of Prescription Drug Promotion (OPDP) is planning a study to evaluate the influence that statements made in a promotional communication about patient adherence t...
Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activ...
http://eyeonfda.com/2023/08/drug-approvals-and-fda-adcomms-in-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. ...
http://eyeonfda.com/2023/08/fdas-opdp-issues-third-letter-of-2023/
In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech ...
http://eyeonfda.com/2023/08/fdas-opdp-issues-second-regulatory-action-letter-of-2023/