BUILDING A MUCH ANTICIPATED DIALOG

摘要

Disappointment was the general industry reaction last fall when the U.S. Food and Drug Administration (FDA) released a preliminary follow-up to its 1987 aseptic processing guidance. While manufacturers praised the effort that went into the agency's 50-page preliminary concept paper, they nevertheless called for significant improvements. And that's just what the agency had in mind. The intention behind releasing a "concept paper" instead of a draft guidance was to offer the industry a preview into agency thinking and solicit feedback for a subsequent draft guidance. The action, which has been hailed as an unprecedented outreach to the industry on behalf of the FDA, accomplished its mission. Feedback was quick to materialize.