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As Prescribed

YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

As summarized in a July 17 LawFlash, FDA has resumed inspections of regulated domestic facilities using a new risk assessment rating system that takes into account the reopening phase of the applicable state, and county level COVID-19 statistics. Based on the risk rating, in any particular US geographic area, FDA may decide to only conduct only mission-critical inspections, inspections with precautions to protect vulnerable staff, or all regulatory inspections. All inspections will be preannounced.

As further described in the LawFlash, companies in need of inspections to support a marketing application or to close out prior inspectional findings should reach out to FDA to discuss the potential for an inspection. Companies should also use this as an opportunity to reassess internal procedures to ensure that they reflect the new realities of conducting an inspection during a pandemic.