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The use of predictive biomarkers for distinguishing promising drug candidates from likely failures could reduce the size of clinical trials and save drugmakers millions of dollars in development costs, according to the FDA’s acting commissioner.
The FDA is requesting postmarketing commitment studies more often, as they are becoming increasingly important in the drug approval process in the U.S., according to a recent study.
The FDA intends to discontinue the use of approvable letters and not-approvable letters for drug marketing applications and instead use “complete response letters” to indicate the review cycle is complete but the application is not ready for approval, the agency announced yesterday.
To help expedite the drug approval process, the FDA is stepping up its efforts to get pharmaceutical companies to submit more complete applications for new molecular entities (NMEs).
The FDA is stepping up its efforts to get pharmaceutical companies to submit more complete applications for new molecular entities (NMEs) — an action the agency believes could expedite the drug approval process.
While the debate over FDA user fees for generic drugmakers has remained dormant in recent years, that doesn’t mean the idea might not come back again, said one agency official.