Nevada Contemplates The Meaning Of “FDA Approved”
This article was originally published in The Pink Sheet Daily
After passage of Rx importation legislation, the State Board of Pharmacy must weigh the attorney general’s opinion that the law is unworkable because of an inability to verify the manufacturing facility.
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Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.
Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.