How are remote regulatory assessments conducted?

How to find an answer to a regulatory question without missing any official sources of information

Challenge

The FDA guidance document search tool allows you to identify documents by topic or a keyword match with the document title. This leaves you with a lot of uncovered information found in the 1000s of guidance documents published by FDA. Conducting comprehensive regulatory searches is critical to minimizing your team's blind spots.

Features Used

Method

Using Cedience's intelligent search, set the filters on FDA guidelines and ask your question. The response will summarize findings from all current (and if you'd like archived) FDA guidance documents.

In this case the question asked is,

How are remote regulatory assessments conducted?

Findings

Here's the answer Cedience's intelligent search returns:

Remote Regulatory Assessments (RRAs) are examinations of FDA-regulated establishments and/or their records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements.

RRAs may consist of or include a request to conduct voluntary remote interactive evaluations.

These evaluations are conducted at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under FDA’s bioresearch monitoring (BIMO) program.

FDA may consider the use of a remote interactive evaluation for any of the inspection program areas.

If the remote interactive evaluation is intended to supplement a scheduled inspection, then FDA usually will combine any observations from the remote interactive evaluation(s) into a single written list of observations issued at the close of the inspection.

FDA may request a remote interactive evaluation for Pre-Approval Inspections (PAIs) when a facility has an acceptable inspection history with no data integrity or other concerns that FDA determines require an inspection and specific application considerations and CGMP manufacturing risks that warrant a PAI can be sufficiently assessed through a remote interactive evaluation.

After the remote interactive evaluation concludes, FDA will generally provide a copy of the final remote interactive evaluation report to the facility. A remote interactive evaluation report and any written list of observations may be subject to a disclosure request under the Freedom of Information Act.

If FDA determines that an inspection will be necessary based on the outcome of the remote interactive evaluation, they intend to use the information obtained from the remote interactive evaluation to prepare for and conduct the inspection.