FDA Press Releases – First Half of 2015

As regular readers may remember, I have started a database that tracks FDA press releases that goes back through 2014 and provided an overview of the 2014 press releases (See – FDA Press Releases – What They Said and How They Said It) after the year was out. Additionally in the first quarter of 2015, I compared that quarter to the same quarter the year before (see “FDA Press Releases – First Quarter 2015). Time to take a new look at the first half of the year – comparing the first quarter of this year to the second and then comparing the first half of 2015 to the first half of 2014.

First, let’s look a bit at this past quarter of this year compared to the first quarter of 2015.

  • There have been 73 releases during the first half of 2015 but that reflects a considerably slowed down pace in the second quarter  – in fact slower by almost half (47 in the first quarter compared to just 26 in the second quarter).
  • Of the 73 releases this quarter, a total of 44 were announcing approvals. That was a fast past in the first quarter with 30, but again slowing down considerably with 14 approval announcements in the second quarter.

Looking at this year so far compared to the first half of last year in terms of volume – there were 75 releases in the first half of 2014, compared to 73 in 2015. While during the first quarter there was a robust release of news from FDA making it look like we were headed for a much larger number this year, the second quarter slowdown had an effect.

Looking at the types of releases, the one thing that stands out is that the number and proportion of approval announcements during the first half of 2015 exceeds that of 2014 (64 percent compared to 52 percent). There were also a few more legal actions taken in 2015, though far fewer rules/guidances announced.

It is important to note as far as approvals are concerned, that FDA does not issue a release regarding every single approval – this represents only those approvals accompanied by an announcement by the agency. Also it should be noted that approvals include device as well as pharma and biologic approvals.

Bottom line – The agency got off to a roaring start in 2015, but the pace has slowed down quite a bit.

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