Tag: Untitled Letter

Untitled Letter

Off-label Promotion

Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

Oct. 19, 2018 — The FDA’s Office of Prescription Drug Promotion (OPDP) issued two enforcement actions in less than a week that focused on alleged safety and risk information infractions for products with Boxed Warnings; both matters were brought to the agency’s attention through OPDP’s Bad Ad program. “These letters are significant not because they […]

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Regulatory/FDA

EstroGel Sell Sheet Efficacy Claim Cited in 4th OPDP Enforcement Letter of 2018

EstroGel Sell Sheet Efficacy Claim Cited in 4th OPDP Enforcement Letter of 2018

Aug. 30, 2018 – In its fourth enforcement letter of 2018, the FDA’s Office of Prescription Drug Promotion (OPDP) cited ASCEND Therapeutics US LLC for allegedly false claims in a sell sheet for EstroGel® 0.06%, stating that the sell sheet “is concerning because it falsely suggests that EstroGel contains the lowest effective dose of estrogen […]

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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

False/Misleading Risk, Efficacy Claims in Online Video Cited in OPDP Enforcement Letter to Pfizer

False/Misleading Risk, Efficacy Claims in Online Video Cited in OPDP Enforcement Letter to Pfizer

July 2, 2018 – The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter in 2018 to Pfizer Inc., claiming that a direct-to-consumer (DTC) video for the ESTRING® (estradiol vaginal ring), posted on the michiganmomliving.com site, as well as prepared Q&As provided to interview participants (and submitted to the agency under Form […]

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Regulatory/FDA

First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid

First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid

Feb. 23, 2018 – Companies, especially those that make opioid products, should make sure that promotional material displayed at conference exhibit booths clearly communicate their products’ risks and limitations of use, and that they heed advisory comments from the Office of Prescription Drug Promotion (OPDP), which issued an Untitled Letter to Collegium Pharmaceutical Inc. on Feb. […]

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Regulatory/FDA

OPDP Enforcement Letter Grand Total for 2017: Five

OPDP Enforcement Letter Grand Total for 2017: Five

Jan. 24, 2018 – In a dip from previous low-enforcement letter years, the Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters in 2017, fewer than half the number of letters issued in 2016 (11). Of the five enforcement letters sent this year, two were Untitled Letters and three were Warning […]

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CHC News

Report from the Coalition Executive Director

Report from the Coalition Executive Director

Nov. 8, 2016 – When the votes are counted, expect many discussions on what will happen next. One thing is certain – there is change ahead. To get the real skinny on what will happen to medical marketing, attend the Coalition for Healthcare Communication post-election meeting next Wednesday and Thursday in Washington. Speakers from throughout […]

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