Our intention with the Regulatory Affairs section of this blog is to facilitate conversation and to report on what we believe to be factual but quirky items. Hence our first entry: Timing is everything, or is it?

This morning while cruising the web we tripped on an interesting factoid direct from The FDA's Site. It says that more New Drug Applications are made in Q4 than in Q1, Q2, and Q3 and that the approval percentage average in Q4 is the lower (26%) than in the other quarters (64%)

For more info see chart below. For still more info go here More from the FDA Site

So what does that mean to you, we ask. If you have a December submittal target should you wait until January when your chances of first round approval go up eighteen points? Should you be extra careful? Are inspectors more diligent in Q4? Are the teams who handle the detail-laden applications in Q4 so busy chomping on leftover Halloween candy and sipping eggnog that they get sloppy? (YES WE ARE KIDDING.)

But we do wonder how the submissions team feels when their product is not approved, especially because a few of the major pharmas have verbiage like this in their job descriptions: Failure to effectively manage the production, assembly and delivery of electronic and/or paper major U.S. and global submissions (e.g. IND, NDA, NDS, EU Dossier etc.) to the appropriate Health Authorities could create a substantial loss of income to the organization and delay in approval for the submissions.

If we're very quiet maybe we'll hear someone scream "No, not to Q4. Let's not make this a Q4 application!"