BIO Submits Comments on FDA Guidance: Conducting Remote Regulatory Assessments – Q&As
On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others. In the comment submitted, BIO expressed general support for the modernization of inspection activities and appreciation for the development of this draft guidance to assist industry with the conduct of RRAs. Given their potential benefits, BIO recommended that FDA leverage these assessments as part of its routine surveillance process. However, BIO requested further clarification on the intended scope and role of RRAs relative to pre-approval/pre-licensure inspections (PAI/PLI). Additionally, BIO recommended that the Agency clarify the similarities and differences in what an establishment might expect to happen during voluntary and mandatory RRAs. As RRAs may be more resource intensive for establishments, BIO suggested that FDA clearly explain the outcomes desired by continual use of RRAs outside public health emergencies along with metrics that could be used to evaluate impact. In addition to specific line edits, BIO also requested that FDA consider the impact and potential unintended consequences of RRAs on GxP facilities, as FDA does not currently use these assessments to indicate or recognize cGMP/GLP compliance.