Pharma Blog Watch

Reacting to Approvable Letters (Eye on FDA)
In his blog, Mark Senak discusses the approvable letter the FDA sent to Cangene in response to the company's application for Accretropin, a recombinant human growth hormone.

"It is interesting … to see how various companies deal with the news," he writes. Cangene's public announcement says that "the FDA requested additional support data regarding manufacturing processes," but doesn't go into detail about the specific issue, Senak points out.

"Other releases go into more detail, but still hold back on specifics, while still others are pretty open and upfront. The issues that everyone cares about is whether there is (i) a safety problem, (ii) an efficacy problem or (iii) a requirement that there be further clinical studies."