Iowa has contracted with a national pharmacy group to inspect facilities outside its borders. Although the program could serve as a potential model for a nationwide plan, it also could bring several problems.

Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.

After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.