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.

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.

House Energy and Commerce members seek input as appropriate mix of incentives for next-generation, public-private ventures remains elusive.

House bipartisan legislators seek input as the appropriate mix of incentives for next-generation public-private ventures remains elusive.

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.

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.