Feb. 28, 2022 – Comments made in a video interview by CytoDyn Inc.’s former president and CEO suggesting that the investigational new drug (IND) leronlimab provides a clinical benefit for those who have COVID-19 were the subject of the FDA Office of Prescription Drug Promotion’s (OPDP’s) first Warning Letter of 2022. “The video makes conclusory […]
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April 30, 2019 – In its first enforcement letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) asserts that an article posted on a sponsor’s website misbrands the investigational drug “Sodium Acetate C-11” (11-C Acetate) because it suggests in a promotional context that the drug is safe and effective for the purpose for […]
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July 11, 2018 – A booth display and a webpage for the investigational new drug (IND) Crenolanib besylate “suggest, in a promotional context” that the IND is safe and effective for the purposes for which it is being investigated and, therefore, misbrand it, according to an Untitled Letter issued June 28 to Arog Pharmaceuticals Inc. […]
Read moreJan. 3, 2017 – In its last blast of 2016, the FDA’s Office of Prescription Drug Promotion (OPDP) sent Untitled Letters to two companies on Dec. 21, both citing videos available on YouTube that allegedly promote investigational new drugs (INDs) as safe and effective for the purposes for which they are being investigated. These Untitled […]
Read more Sept. 15, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has only issued four enforcement letters this calendar year, it issued two Untitled Letters within two weeks for the same alleged infraction: promoting an investigational drug. In a Sept. 8 letter to DURECT Corp. and Pain Therapeutics Inc. (remoxy-untitled-letter), OPDP raised concerns […]
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