FDAnews Drug Daily Bulletin

FDA WORKS TOWARD IMPROVED DRUG PIPELINE THROUGH PRESUBMISSION POLICY

April 27, 2006
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Formalizing presubmission reviews of drug applications will improve the drug pipeline by cutting down on both regulatory and industry inefficiency, Andrew von Eschenbach, the agency's acting commissioner, says.

The FDA is developing guidance establishing steps the agency and drug manufacturers must take when considering drug applications before formal submission, von Eschenbach said during a recent session of the FDA's 2006 Science Forum.

"The FDA is the bridge that anchored in discovery and anchored in delivery," and it is up to the agency to ensure that companies are able to get from one end to the other as efficiently as possible, von Eschenbach said. For example, the FDA is working to smooth the introduction of vaccines, antivirals and devices to address the pandemic flu threat by formalizing the preapplication steps both the agency and industry should take, he said.

The FDA is currently reviewing previous presubmission reviews to develop a battery of best practices to inform future reviews, von Eschenbach told FDAnews. The guidance will address both industry and agency best practices, ending what has previously been an ad hoc approach, he added. The agency has not set a deadline for this guidance, he said.