Bowman Cox
Executive Editor
Latest From Bowman Cox
Emergent Suspends COVID-19 Vaccine API Manufacturing As US FDA Inspects Bayview Plant
After discovery of viral vector cross-contamination, AstraZeneca quit, J&J took control and the FDA launched inspection.
Industry ICH Proposal Would Limit International Regulatory Oversight Of Manufacturing Models
The focus would be on high-impact changes to high-impact models under approach advocated by BioPhorum, IQ Consortium and PPAR.
Remote Site Visits Will Help US FDA Keep Reviews On Track As Pandemic Constraints Continue
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.
Remote Site Visits Will Help US FDA Keep Reviews On Track During Remainder Of Pandemic
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.
Revised US Approach For Parenteral Drug Leachables Could Prevent Regulatory Missteps
Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.
Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable
Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.