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Sequestration Takes Hold: Full FDA Impact Remains To Be Seen

This article was originally published in The Gray Sheet

Executive Summary

FDA does not plan to furlough employees as a result of the across-the-board cuts to federal agencies that took effect March 1, but the shortfall will limit some “activities that have already been specifically designated and paid for with user fees.” The administration also took a step to convince Congress to give FDA full access to its user fees.

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Final Coverage-With-Evidence-Development Guidance Delayed By CMS Staff Cuts

The CMS coverage and analysis group has had to divert its attention from finishing a CED guidance to finalizing proposed changes to the process for awarding Medicare coverage for IDE trials, primarily due to staff cuts, says Louis Jacques, who heads the group.

CDRH Sequestration Impact: Training, Standards And Reg Science

CDRH Director Jeffrey Shuren detailed last week how federal sequestration cuts to FDA are impacting specific device center programs, including training, standards development and regulatory science. Shuren also signaled imminent policy releases from the center, including a finalized post-market surveillance plan.

Reimbursement In Brief

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