May 23, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued just three Untitled Letters to date in 2014, but all of them cite companies for omitting risk information or omitting material facts in various promotional venues, including a printed sales aid, a Facebook page and a sales sheet. “Clearly, omission of […]
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omission of riskOPDP Enforcement Letters Target Common Issues in Last Half of 2013
Feb. 4, 2014 — Many of the 14 enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) cited similar allegations it has cited in the past, including omission of risk information, unsupported superiority claims and overstatement of efficacy, according to OPDP officials who responded Jan. 30 to questions about the three Warning […]
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