FDA's RSS Feeds -- they're batting .555

The FDA provides a collection of 9 RSS Feeds for its various sub-domains.

5 of the 9 feeds are actually useful (Consumer Health Info, MedWatch Safety Alerts, News Releases, Recalls, What's New @ CDRH).

The other 4 are borderline pointless. It's not that the topics are pointless. Hell, I'd be interested in actually getting a glimpse as to what's new @ CDER & CBER. But take a look at the Feeds.

Enforcement Reports is simply a running list of when the FDA releases its weekly enforcement report, but there's no summary information provided in the feed itself. The content of each weekly report should be a feed itself.

What's New @ CDER & CBER aren't much better.

What's New @ the Center for Food Safety has a whopping single entry over 1 month old.

Why don't we just get rid of the food feed and put a little more meat into the others?

My Confusion about Postmarket Requirements & Study Commitments

FDA has a database of postmarket requirements and study commitments (translation: "we're going to approve your drugs, but you have to promise to run these additional trials after we approve").

This database is updated quarterly and FDA even provides its own search engine to mine this database.

I've only been indexing their collection of data for a couple of quarters, but with the most recent update (April 30), I noticed something that I hadn't realized before.

Specifically, each new quarter's data *wipes out* the previous quarter's data. For example, the January 31 update contained 3381 postmarket requirements that could be searched via FDA.

In contrast, the April 30 data release contains only 1910 requirements. So, it looks like the FDA removes commitments that have been satisfied (I'm not 100% sure about the precise commitments that are removed each quarter, but this seems like the most reasonable explanation).

In practice, this means that you can't use FDA's search-engine to get a historical look at the types of commitments/requirements that were mandated by the FDA.

For example, if you search the FDA's postmarket requirements database for Zoladex you get no results. If you search using FDAble, you'll see that Astrazeneca UK had 3 requirements relating to Zoladex that were fulfilled in 2008.

I imagine that this historical information would be useful to many people (clinicians, persons performing competitive intelligence & strategy regarding drug development, etc.).

FDA's web-facelift

The FDA revamped much of its website last week (e.g., http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm).

Can you guys give me a heads-up next time you do something like this (;-))? It's like when my mother-in-law comes over and moves all the drinking glasses to a new cabinet.

At first glance the change appears to be largely cosmetic, but it's a nice touch--what with the drop-shadows and all.

Aaaaaaaand we're back

the horror is mostly over.