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The FDA’s plan to require more stability data for ANDAs is likely to slow approvals unless the agency flexes a little, generic-drug makers say.
CDER plans to standardize REMS development to make the safety tools more effective and less burdensome for drugmakers.
Abbott and Reata Pharmaceuticals are halting a Phase III trial of kidney disease drug bardoxolone after an unspecified number of patient deaths.
Amgen and Novartis want the FDA to clarify which compounds would require an assessment of suicidal thoughts and behaviors under draft guidance the agency issued in August.
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