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Code · CFR · Title 21 — Food and Drugs · Part 314 — Applications for FDA Approval to Market a New Drug · § 314.540

§ 314.540. Postmarketing safety reporting.

28 words·~1 min read·/us/cfr/t21/s§ 314.540·

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Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved drug products, as provided in §§ 314.80 and 314.81.
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