Dec. 13, 2021 – Recent FDA Warning Letters calling out promotional claims made about vaping products are interesting in that they were issued not by the agency’s Center for Tobacco Products, but by the Center for Drug Evaluation and Research (CDER). “Although the FDA has been criticized for missing deadlines on approving or rejecting various […]
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Oct. 4, 2018 – According to Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock, the FDA’s Office of Prescription Drug Promotion’s (OPDP’s) decreased number of enforcement actions is largely due to the agency’s concerns regarding First Amendment issues that have been raised in recent court rulings. Speaking at a Sept. 21 discussion […]
Read moreDec. 21, 2016 – The late year spate of enforcement letters from the FDA’s Office of Prescription Drug Promotion (OPDP) continued on Dec. 13 with two new Warning Letters sent directly to company heads, bringing the number of Warning Letters to three this year, plus six of the lesser Untitled Letters. How clearly product risks […]
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July 22, 2016 – Although 2015 was considered a slow year for enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) – just nine total enforcement letters – so far this year OPDP is lagging behind that figure, having issued only one Untitled Letter and one Warning Letter between the beginning of […]
Read moreJan. 25, 2016 – The Office of Prescription Drug Promotion (OPDP) kicked off 2016 with a Jan. 14 Untitled Letter to Hospira Inc., a Pfizer company, citing a video posted on YouTube that presents information about what to expect from Hospira’s Precedex™. OPDP states in the letter that the video “is false or misleading because […]
Read moreNov. 11, 2013 – The FDA Office of Prescription Drug Promotion’s (OPDP’s) recent enforcement actions – four Untitled Letters and two Warning Letters issues since July 1 – include a Nov. 8 Warning Letter to Aegerion Pharmaceuticals Inc. that cites the company not for advertising or promoting its JUXTAPID capsules to physicians or consumers, but for […]
Read moreOct. 15, 2012 – The FDA’s Office of Prescription Drug Promotion (OPDP) recently announced that it will hold its next Enforcement Webinar on Oct. 29, from 11 a.m. to 11:30 a.m. EST. The OPDP enforcement Webinar, which covers Warning Letters and Untitled Letters issued from May 2012 through mid-October 2012, will give stakeholders an opportunity […]
Read moreJuly 16, 2012 – The FDA’s Office of Prescription Drug Promotion (OPDP) is on pace to deliver the same number of enforcement letters it sent out in 2011, having issued 15 Warning or Untitled Letters to date in 2012. OPDP had issued 17 such letters by this point in 2011. The seven enforcement letters sent […]
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