FDA is considering the use of 30% and 40% reductions in glomerular filtration rate as surrogate endpoints for the development of kidney failure in clinical trials; the current standard is 50%.

Sponsors cannot cut corners in developing clinical data to support a revised dosing scheme, even when a drug’s efficacy has already been shown, Novartis learned while shepherding its kidney transplant agent Zortress (everolimus) through the FDA approval process.

Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.