FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Regulatory Affairs

FDA Posts Draft Guidance for Drugs to Prevent Kidney Delayed Graft Function

March 30, 2017
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Because no drugs exist for delayed graft function prevention, the FDA issued guidance to help foster discussion between drugmakers and the agency on developing drugs to treat the problem.

The FDA hopes to encourage the development of drugs to lower serum creatinine levels, a biomarker of kidney performance.

“The main reason to prevent DGF is to avoid the need for dialysis,” the agency said. The guidance does not address the treatment of DGF or improving draft quality, but notes that those issues may be covered in future guidance.

The agency invited comments on the draft guidance for 90 days.

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