The Quality Lowdown: US FDA Renews Attention To Contamination Challenges
Executive Summary
All-out efforts by agency staff to help industry supply COVID-19 treatments last year were applauded but now its attention returns to the top pre-pandemic priority, contamination risks. Edge Pharma consents to attack mold, Glicerinas blocked over inspection refusal, Bioiberica hit for ‘reprocessing’ contaminated drug substance, Rentschler bashed for inadequate monitoring.
You may also be interested in...
Transparency Looms Large In US FDA’s Next-Pandemic Legislative Agenda
Agency’s proposals for pandemic preparedness reauthorization would build on CARES Act provisions to gain greater visibility into global pharmaceutical supply chains, while also seeking deeper understanding of manufacturing quality management activities. Also included in FY 2024 budget request: long-sought drug destruction and drug recall authorities.
US FDA ‘Brainstorms’ For Ways To Resume Pre-Pandemic Inspection Cadence
The FDA's drug inspections director discusses trends and challenges in remarks at a Georgia GMP conference, while declining to share specific ideas generated in last week’s agency brainstorming session.
For Reauthoring Preparedness Law, Congress Needs Advice On Next Public Health Emergency
House Energy and Commerce members seek input as appropriate mix of incentives for next-generation, public-private ventures remains elusive.