BioCentury
ARTICLE | Regulation

Plans to resume domestic inspections could keep FDA on track with PDUFA timelines

July 10, 2020 11:37 PM UTC

Despite the pandemic, FDA is on track for a banner year for new drug approvals, and its plan to gradually resume domestic inspections starting the week of July 20 could help keep it on track in the second half.

Travel restrictions due to COVID-19 led FDA to halt in-person inspections starting in March, though the agency has continued to conduct inspections it deems “mission critical.” ...