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.

sticky notes
it will be better than sticky notes • Source: Shutterstock

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.

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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff

 

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

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One CDRH employee said the cuts already are having a major effect on morale.

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Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."