The US Food and Drug Administration’s plan to exercise more authority over lab-developed tests came one step closer to fruition this week, as the White House Office of Management and Budget announced on 22 April that it had completed its review of the final rule. OMB review is the last step before a document can be officially published.
The OMB cleared the rule as “consistent with change.” This means that the office sent the rule back to the FDA with some changes, though it’s impossible to know what...