New Safety Framework Mixes Current Efforts, New Investments At US FDA
In a new "action plan," FDA is stitching together a plethora of ongoing and proposed initiatives to help spur product safety and quality efforts through increased regulatory authority and more incentives for device-makers.
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Recent medical journal papers call into question the effectiveness of the US agency’s medical device surveillance system, arguing that it’s too slow to pick up on safety signals.
A public-private partnership board long touted by top US FDA officials to help address cybersecurity threats has hit a funding wall. The agency received less than half of what it asked for in the FY 2019 budget for its digital efforts, including its cybersecurity strategy, leading it to make some tough choices.
Acting US FDA Commissioner Ned Sharpless described his vision for an efficient, adaptable agency on 2 May at the Food & Drug Law Institute’s annual conference in Washington, DC.