Tag: OPDP research studies

OPDP research studies

Regulatory/FDA

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

March 28, 2022 – As FDA Commissioner Robert Califf, M.D., determines how to fulfill his promise to re-examine the agency’s accelerated approval pathway and Congress continues to push for action, the FDA’s Office of Prescription Drug Promotion (OPDP) is tackling one piece of the puzzle: How well consumers understand the limitations of accelerated approval drugs […]

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DTC Advertising

Citizen Petition Says Music in DTC Ads Distracts from Risk Info, Calls for FDA Ban

Citizen Petition Says Music in DTC Ads Distracts from Risk Info, Calls for FDA Ban

Aug. 3, 2020 – The background music in direct-to-consumer (DTC) ads “is a distraction from the presentation of risks … and bombards the viewer with excess stimuli making it difficult for them to retain the information,” according to an Aug. 3 Citizen Petition sent to the Food and Drug Administration (FDA) by Knowledge Ecology International […]

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DTC Advertising

OPDP DTC Research Studies Await Peer Review, Are Poised for Publication

OPDP DTC Research Studies Await Peer Review, Are Poised for Publication

Sept. 16, 2019 – Five research studies conducted by the FDA’s Office of Prescription Drug Promotion (OPDP) – four of which examine aspects of direct-to-consumer (DTC) advertising – are complete and awaiting peer review and publication, according to OPDP’s Website. “Taken together, the OPDP studies now nearing release will make an important contribution to the […]

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Regulatory/FDA

OPDP to Study How Source, Graphics and Time Affect Physician Perceptions of Info

OPDP to Study How Source, Graphics and Time Affect Physician Perceptions of Info

Aug. 26, 2019 – How healthcare professionals are influenced by different factors in prescription drug journal abstracts or sales aids – context, rigor of the underlying clinical study and time – is going to be examined by the FDA’s Office of Prescription Drug Promotion (OPDP). In a recent Federal Register notice, the agency stated that […]

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Regulatory/FDA

Three New OPDP Research Studies to Cover Broad Array of Promotional Activities

Three New OPDP Research Studies to Cover Broad Array of Promotional Activities

Oct. 22, 2018 – Broadcast disease awareness ads, accelerated approval disclosures in direct-to-consumer (DTC) ads, and physician interpretation of drug information in scientific publications as compared to promotional pieces are the subjects of future Office of Prescription Drug Promotion (OPDP) research, according to notices published Oct. 17 in the Federal Register. “All three of these […]

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