FDA’s LDT Review Clears OMB Review, But Shutdown Could Delay It

FDA has received the nod from the White House budget office to propose a controversial rule asserting the agency’s authority to regulate laboratory developed tests (LDTs), but a potential government shutdown should Congress not fund the government starting Oct. 1 could delay the rulemaking process. The White House Office of Management and Budget concluded its review of the rule Tuesday (Sept. 26), clearing the way for FDA to issue a Federal Register notice. However, as of Thursday (Sept. 28),...