FDA Seeks to Match HHS’s New Human Research Review Mandate

May 9, 2018, 9:08 PM

The FDA appears to be taking initial steps to align with a major Obama-era human research rule.

The regulatory agenda released May 9 includes several new items from the Food and Drug Administration to update how it regulates institutional review boards, which review studies to ensure they adequately protect research volunteers.

FDA officials have said for years they will align their regulations with the Common Rule, a set of human subject protection regulations adopted by nearly 20 agencies. The unified agenda marks the first concrete, regulatory step in that direction.

The new unified agenda items include:

  • changing regulations when ...

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