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The Food and Drug Administration has resumed domestic biopharma inspections for the first time since March 2020. But not surprisingly, the agency finds itself confronting a major pandemic backlog. At a regulatory event this week, acting FDA commissioner Dr. Janet Woodcock announced that, as of July, the agency had “begun transitioning back to standard operations for domestic inspections, while continuing to prioritize mission-critical work for foreign inspections.” A halt in on-site visits during the COVID-19 pandemic led to an accumulation of more than 8,000 delayed non-mission-critical surveillance inspections – including food and drug products – as well as around 50 delayed human drug applications. While experts agree the announcement represented a step in the right direction, a return to some semblance of normalcy won’t come without its challenges.

Michael caromeJanet woodcockMary denigan macauleyHealth research groupDrug administrationUs government accountability officePublic citizenAccountability officeஜேனட் மரக்கட்டைஆரோக்கியம் ஆராய்ச்சி குழுஎங்களுக்கு அரசு பொறுப்பு அலுவலகம்பொது குடிமகன்பொறுப்பு அலுவலகம்