Tag: FDA enforcement

FDA enforcement

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

CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

March 7, 2018 – The Center for Biologics Evaluation and Research’s (CBER’s) Advertising and Promotional Labeling Branch (APLB) may not exactly be an enforcement powerhouse, issuing just three Untitled Letters since 2013, but it found fault with CSL Behring LLC’s Website, patient brochure, exhibit panel and sales aid for IDELVION® because these promotional materials allegedly […]

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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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Regulatory/FDA

OPDP’s Third Enforcement Letter of 2017 Cites Presentation of Risks, Efficacy Claims

OPDP’s Third Enforcement Letter of 2017 Cites Presentation of Risks, Efficacy Claims

Nov. 30, 2017 – False or misleading risk presentation and claims about efficacy were the primary concerns listed in the Office of Prescription Drug Promotion’s (OPDP’s) second Warning Letter of the year, demonstrating that the issues cited in previous years’ enforcement letters remain a priority for the agency. “While this is only the third enforcement […]

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DTC Advertising

OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

Dec. 15, 2016 – Television ads allegedly making false and misleading claims about the risks associated with their products were cited by the FDA’s Office of Prescription Drug Promotion (OPDP) in Untitled Letters issued Dec. 12 to Celgene Corp. and Sanofi-US. These letters bring the total number of Untitled Letters issued this year up to […]

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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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