FDA Revises Draft Guidance on Remote Regulatory Assessments

The FDA revised a draft guidance Thursday on its use of regulatory remote assessments and its process for facilitating evaluations outside of the Covid-19 public health emergency.

Remote regulatory assessments are tools the Food and Drug Administration introduced in response to the pandemic to provide continued oversight of the regulated industry while responding to Covid-19 guidelines.

The examinations pertain to FDA-regulated establishments and their records. They are conducted entirely remotely and used to mitigate risk, meet critical public health needs, and help maximize compliance of regulated products, according to the agency.

The draft’s revisions are in response to public comments ...