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Your company makes and sells an approved drug product, but plans to make a few changes. Which of the following changes can be made WITHOUT
Your company makes and sells an approved drug product, but plans to make a few changes. Which of the following changes can be made WITHOUT additional FDA approval? (select all answers that apply). Group of answer choices Substantial change in the process technology, but keeping the same amounts of API and excipients in the formulation. Change some of the excipients used in the formulation. Change in the type of packaging for tablets - use blister packs instead of bottles. None of the above
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