When I asked an FDA official what prompted the agency to issue the draft guidelines, he said people were seeking clarification of the 36-year-old regulation as well as the previous draft guidance, which was issued in 1987. That’s reasonable. However, the FDA should have checked with industry sources before issuing the draft. It could have avoided confusion over the use of basic terms such as “semi-finished” and “uncut” as well as learned about the effectiveness of current drop ball testing methods, which many believe are adequate.
Responding to industry requests the FDA is extending the deadline for public comment until late April. That’s encouraging and indicates the FDA is willing to get as much feedback as possible before taking any action.
I invite readers to submit comments to the FDA’s Division of Dockets Management (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Refer to docket number fr26oc07-76.