Tag: promotion

promotion

Regulatory/FDA

Exhibit Booth and Webpage Misbrand IND, OPDP Says in Enforcement Letter

Exhibit Booth and Webpage Misbrand IND, OPDP Says in Enforcement Letter

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. […]

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Regulatory/FDA

FDA Calls for Additional Comment on Revised Intended Use Language

FDA Calls for Additional Comment on Revised Intended Use Language

Jan. 15, 2018 – The FDA is delaying until further notice the effective date of a Jan. 9, 2017, final rule describing the types of evidence that may be considered in determining a medical product’s intended use so it can consider the comments and a citizen petition already received on that rule and collect additional […]

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OPDP: There Are “A Number of Things” Companies Can Do to Avoid Enforcement Actions

July 29, 2013 — The FDA’s Office of Prescription Drug Promotion (OPDP) held a Webinar today to discuss and take questions about the seven Untitled Letters it has issued from April through June of this year. When asked by the Coalition for Healthcare Communication how the drug industry can better avoid enforcement actions, OPDP Regulatory […]

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Study Cites Benefits of Pharma’s Promotional Efforts

March 4, 2013 – A recent study released by the National Bureau of Economic Research (NBER) states that although consumer-directed drug promotion increases utilization and thus overall drug costs, it also helps to educate consumers, induce physician contact and promote adherence. “It’s refreshing to see a balanced study of DTC,” notes John Kamp, Executive Director […]

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