Latest From Bowman Cox
After discovery of viral vector cross-contamination, AstraZeneca quit, J&J took control and the FDA launched inspection.
The focus would be on high-impact changes to high-impact models under approach advocated by BioPhorum, IQ Consortium and PPAR.
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.
Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.