Expert Committee Recommends Patient-Focused Dissolution Standards

An FDA advisory panel voted unanimously to recommend that the agency establish patient-focused dissolution standards for extended-release solid oral dosage forms.

In the 11-0 vote, members of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee affirmed the need for such standards within the industry.

“There’s no question this would be a valuable scientific enterprise and, properly explained to the public, I believe it’s something that’s going to have wide support,” said temporary voting member Paul J. Smith, director of the University of Maryland’s statistics program.