US FDA Advertising Citations Remain Rare In 2018
With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.
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US FDA Loss In Device Case Might Have Implications For Agency’s Work On Off-Label Rx Promotion
While the statutes at issue in the case, which revolved around banning just one use of a medical device, do not govern drugs, experts on FDA law said the decision addressing a product’s intended use and regulation of the practice of medicine could have some impact on the agency’s Rx oversight powers.
FDA Objects To ‘Pretty Easy, Huh?’ TV Ad For Gvoke Injection Diabetes Drug
In its second letter of the year, US Office of Prescription Drug Promotion says Xeris Pharmaceuticals’ television ad fails to include important risk information and misleadingly suggests Gvoke pre-filled syringe can be easily used.
US FDA Puts Spotlight On Alkermes' Violative Vivitrol Ad
The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.