Lawyer Unclear About FDA’s Site Visit Policy For COVID-19 Vaccine EUAs

FDA has indicated that it might not conduct pre-approval inspections of sites that are manufacturing COVID-19 vaccines and that are being considered for emergency use authorization, but there’s a lack of clarity about the agency’s alternative approaches to site inspections. Namely, agency officials have said that FDA will rely on other information to assess manufacturing compliance, including “site visits,” a term that one regulatory lawyer said she’s never before heard FDA use. Questions about FDA’s inspection plans for COVID-19 vaccines...