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When a sponsor wants to begin testing a new product, they must follow FDA Regulations ( 2 1 CFR part 3 1 2 ) ?referred

When a sponsor wants to begin testing a new product, they must follow FDA Regulations

(21

CFR part

312)

?referred to as a "Notice of Claimed Investigational Exemption for a New Drug". This application must be filed with FDA and is also referred to as:

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