FDA Warning and Untitled Letters Combined List 2021

  • 2021 – In 2021, FDA’s OPDP has issued a total for 4 regulatory action letters
    • 7.14.2021 – AmgenUNTITLED LETTER – for Banner Ad related to Neulasta – unsupported claim
    • 3.8.2021 – Biohaven Pharmaceuticals – UNTITLED LETTER – for DTC Video related to NURTEC – risk minimization, superiority claim, unsubstantiated claim
    • 2.23.2021 – CooperSurgical Inc WARNING LETTER – for DTC Video related to ParaGard for risk minimization
    • 2.11.2021 – AcelRx Pharmaceuticals WARNING LETTER – for a display ad and a banner ad related to Dsuvia for risk minimization