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    FDA Medication Error Review for NDA 018680 Paragard – Memorandum Dated Dec 23, 2022

    FDA Medication Error Review for NDA 018680 Paragard – Memorandum Dated Dec 23, 2022

    $69.00 USD
    $69.00 USD
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    Original Request: An authentic, certified copy of the Memorandum: Medication Error Review, dated December 23, 2022, regarding NDA 018680, Paragard (copper) intrauterine system, TTT ID # 2022-2745 with a Reference ID: 5100461. This document was embedded in a Spotlight on America article from November 14, 2024 -- "FDA launched safety review into broken IUDs after Spotlight inquiry, but questions remain" (Attached, for reference, as Exhibit 1).
    Tags: MedTech, Recall, 2022
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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