16 CFR 1702.16 – Petitions requesting an exemption for a drug or a new drug
Current as of: 2024 | Check for updates
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(a) Where the petition requests an exemption for a drug, as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321(g)(1), the petitioner shall include those reports required to be filed under the Food and Drug Administration’s Adverse Reaction Reporting Program.
(b) [Reserved]