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Where can I find additional information on the time and extent application?

April 26, 2017additional application extent time

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Where can I find additional information on the time and extent application?

2 Answers

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The final regulations (21CFR 330.14) for criteria and procedures for a Time and Extent Application (TEA) were published in the Federal Register on January 23, 2002. A copy of the Final Rule is available. A Draft Guidance for Industry for TEA applications is available as well.

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Posted

The final regulations (21CFR 330.14) for criteria and procedures for a Time and Extent Application (TEA) were published in the Federal Register on January 23, 2002. A copy of the Final Rule is available. A Draft Guidance for Industry for TEA applications (PDF – 46KB) is available as well.