Latest From Bowman Cox
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.
US Lawmakers Seek Next-Pandemic Advice For Renewing Preparedness Law
House bipartisan legislators seek input as the appropriate mix of incentives for next-generation public-private ventures remains elusive.
US FDA’s Woodcock Outlines Plans For Quicker Inspection Workflow Platform, Expected Next Year
Inspection ordering and case management software launched with food program revamp will bring real time coordination between the US FDA’s inspectorate and all its centers, enabling quicker, surer deployment and better development of cases against sites found to have poor manufacturing practices.
US FDA Expands KASA Platform To Probe API Synthesis, Conduct NDA Quality Reviews
Agency builds on success with last year’s KASA-based ANDA quality reviews to widen and deepen the software tool’s functionality, says CDER OPQ leadership. CMC assessors are adapting quickly to a platform that could soon alert them to issues like possible genotoxic impurity formation during API synthesis.