Ball In Judge’s Court In Combination Product Classification Suit
This article was originally published in The Pink Sheet Daily
All the planned briefs have been filed in a case, Prevor v. United States Food and Drug Administration, that could have important implications for how FDA designates a product for either device or drug primary review.
You may also be interested in...
The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.
US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.
No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had a designation-decision appeal "under consideration" for 18 months and counting.