Rules Relaxed for Changes
Pharmaceutical & Medical Packaging News
February 2000 In many cases, postapproval packaging changes will no longer have to be approved by FDA prior to implementation. For years, industry has been asking FDA to allow more leeway with postapproval changes to packaging. It finally got its wish when FDA's Center for Drug Evaluation and Research (CDER) published the guidance document "Changes to an Approved NDA or ANDA" in November. Some of the new guidelines give industry even more latitude than what it originally asked for. The guidance is a result of the FDA Modernization Act (FDAMA) of 1997, which mandated fewer restrictions on changes.
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