According to Alexander Gaffney of raps.org FDA confesses that the guidance process is slow and not accessible. Complaints pertaining to lack of transparency and length of time before guidances are in full effect have led FDA to release the Level 1, IIE guidance documents. The IIE guidance documents will be used “when prior public participation is not feasible or appropriate.” The documents will still be released through the Federal Register postings, but the difference is the speed relative to the policy change. In order for the IIE guidance documents to be taken advantage of they must meet three criteria:
- New scientific information has been identified that raises new risk/ benefit information
- FDA’s regulatory expectations change as a result of (1)
- Public comment is not feasible based on time constraints
The IIE documents will be relatively short comparatively to other guidance documents and will have a comment period of 60 days after its release for the industry to weigh in. To read the full article click here.