FDA new FINAL Guidance: CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality

For my CMC colleagues, this will be of interest. I didn't know what a "voluntary consensus standard" meant, and fortunately the Guidance addresses that as a foot note to the Introduction:

"a standard that is developed or adopted by domestic and international voluntary consensus standards bodies . . . . These bodies often have . . . policies that include provisions requiring that owners of relevant patented technology incorporated into a standard make that intellectual property available to implementers of the standard on non-discriminatory and royalty-free or reasonable royalty terms."

My initial thinking in reading this was "OK - NIST, USP" but another footnote indicates that other bodies can submit to have other standards recognized: "Although regulated industry would be the primary user of standards that are within the scope of this program, any interested party may request recognition of a standard. "

It's also noted that CDER’s program is different than the standards recognition program in the CDRH.

To read the new final guidance, access it here: https://www.fda.gov/media/121305/download