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.
The US Food and Drug Administration is working to establish a new platform for ordering inspections by fiscal year 2024, with back-end improvements in enforcement and case management efficiencies to follow, the agency’s principal deputy commissioner Janet Woodcock said 2 March.
The agencywide inspection workflow solution will replace a patchwork of processes that failed to prevent last year’s infant formula crisis....
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
