But the proposed regulations are tougher, including four reporting categories for post-approval changes based on the potential for the changes to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to its safety and effectiveness. For example, the proposed rule would require manufacturers to file a supplement with FDA 30 days before making any change within the container closure system for a sterile liquid dosage form. This would be required even when the manufacturer can show the change is based on equivalency to the approved system as indicated in a protocol in the approved application or published in an official compendium.
FDA eyeing changes in drug packaging regulations
FDA is finalizing its rule on reporting requirements for changes to drug packaging made after approval of a new drug application. Currently, the drug manufacturer need only note the changes in its annual report to FDA.
Nov 30, 2001
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