The image reflects results from 3 years ago, when a diverse group of participants, including HF service providers (HFSPs) from pharma, biotech, and consultancies, responded to the question: How often does the FDA reject your HF submission? The results were as follows: Never: 35%, Sometimes: 60%, Most of the Time: 5%.

However, as per data shared by the FDA/CDRH HF Premarket Review Team (BTW, how long ago?), HF reports are sent back  (rejected) more than 90% of the time. 

If am not wrong, FDA’s data were collected in 2018/2019? It would be interesting to know if anything has changed? Is the rejection rate still over 90%? Moreover, addressing the discrepancy between the FDA’s findings and the industry’s perspectives would be also interesting.

In my opinion, this discrepancy may be attributed to different definitions of success. And while we are on the subject, I would like to pose another question: Could it be that HFSPs, whether from a manufacturer or consultancy firm, find it challenging to acknowledge failure in this context? Perhaps there is a social desirability bias at play.  I had discussed it before, but I am eager to hear your thoughts, what do you think?

Furthermore, we are in the process of updating the initial question. Please click below to anonymously cast your vote.  The cumulative results will be shared on a subsequent article. 

Your participation is crucial in shaping our understanding of this critical issue. We highly appreciate your contribution to the conversation.

Your vote is important, and rest assured that your participation will remain anonymous. Thank you for your valuable input!