It’s always an exciting day when FDA issues the new annual edition of the Orange Book! (At least for me, and I’m sure also for Kurt Karst, over at FDA Law Blog.) There are a lot of changes in store at the Orange Book in the next year, all of which will get fanfare and attention, but this post is about the little changes in the annual edition (print and PDF) that don’t get called out. It’s prompted by the fact that FDA deleted a sentence in the preface last year, without telling anyone. (I had quoted it in an expert report, just a few months earlier and was annoyed to see it deleted.) I resolved that going forward I would electronically compare every new annual edition to the last year’s edition, and so I spent my Saturday doing exactly this with the new edition — and crashing my computer repeatedly. The results after the jump.
Continue reading “Changes in the new Orange Book — or, too much time on my hands …”