Tag: investigational new drug

investigational new drug

Regulatory/FDA

OPDP Issues Enforcement Letter for Investigational Drug Promotion

OPDP Issues Enforcement Letter for Investigational Drug Promotion

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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Regulatory/FDA

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

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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