FDCA And Liability For State Failure-To-Warn Claims

Law360, New York (January 25, 2010, 11:43 AM EST) -- Federal law requires pharmaceutical manufacturers to obtain approval for drug products from the U.S. Food and Drug Administration prior to marketing. See Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq.

Pursuant to the FDCA, a manufacturer must show that the product is safe and effective for use under the conditions prescribed, recommended or suggested in the proposed labeling. 21 U.S.C. § 355, FDCA 52 Stat. 1040. Likewise, FDA approval for the labeling on pharmaceutical products must be obtained prior to marketing. Id....
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