Last week in this space, we looked at what a Form 483 can do to a pending application, and how a single set of inspectional observations can reset a review clock. This week, we turn to the sequel: what happens after the observations land and firms want to respond as swiftly and successfully as possible.
The FDA’s draft guidance on responding to Form 483 observations can be interpreted simply as a tidy how-to guide for firms that want to answer well. But judging by the comments it received, the industry read it rather differently. The recurring worry, voiced most sharply by the biggest names in the room, is that a document ostensibly about formatting has smuggled in something heavier.
A Trojan Horse Full of CGMP
The metaphor practically writes itself, and several commenters reached for it in all but name. A guidance that presents itself as a gift – a template to speed the resolution of a problem – may also be carrying a garrison of new substantive obligations inside its wooden flanks.
The Pharmaceutical Research and Manufacturers of America (PhRMA) warned that the draft “could be interpreted to go beyond the topic of responding to FDA 483 observations and to suggest new substantive current good manufacturing practice (‘CGMP’) expectations.”