Search Results for Office of Prescription Drug Promotion

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FDA Enforcement Trends for Broadcast Advertisements By Justin Mann, Julie Tibbets - Published 28 September 2017

This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information.

Categories: Features, US, FDA, Advertising and Promotion, Drugs

Tags: Office of Prescription Drug Promotion, OPDP, Warning Letter, YouTube, Social Media

FDA Warns Drugmaker Over Opioid Marketing Materials By Michael Mezher - Published 05 September 2017

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has warned Canadian drugmaker Cipher Pharmaceuticals over promotional materials for its combination immediate and extended release opioid ConZip (tramadol hydrochloride).

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: ConZip, OPDP, Warning Letter, Office of Prescription Drug Promotion

OPDP Study Raises Questions About the Balance of Information in Mobile Ads By Michael Mezher - Published 05 July 2017

A new study by officials from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) raises questions about the balance of benefit and risk information in mobile ads for prescription drugs.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: OPDP, Office of Prescription Drug Promotion, Mobile Ads

FDA Promotional Enforcement Actions Hit Record Low in 2015 By Michael Mezher - Published 19 January 2016

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a record-low nine letters to companies for advertising and promotion violations.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: Office of Prescription Drug Promotion, OPDP, Warning Letter

Walking the Digital Tight-Rope By Linda Pollitz, Moulakshi Roychowdhury, PharmD, JD - Published 05 November 2015

On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media.

Categories: Under RAPS, China, US, FDA, Advertising and Promotion, Communication, Drugs

Tags: Social media guidance, Office of Prescription Drug Promotion, OPDP, Regulatory Focus

Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors By Betsy Kurian, PharmD, Moulakshi Roychowdhury, PharmD, JD - Published 09 October 2015

This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies.

Categories: Features, US, FDA, Advertising and Promotion, Compliance, Prescription drugs, Government affairs

Tags: Office of Prescription Drug Promotion, OPDP, Office of Inspector General, (OIG), Untitled letters, Warning letters

The Evolving Approach of Presenting Risk Information to Consumers By Richard Lem, PharmD - Published 25 September 2015

This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency.

Categories: Features, US, FDA, Advertising and Promotion, Compliance, Drugs, Government affairs, Medical Devices

Tags: Office of Prescription Drug Promotion, FDA, draft guidance, social media, drug ads on social media

FDA to Study How Efficacy Information Affects Patients' Decisions in Drug Ads By Michael Mezher - Published 20 July 2015

Does the inclusion of efficacy information in drug advertisements affect how patients perceive a drug, and if so, how would it affect their decision making?

Categories: News, US, FDA, Advertising and Promotion, Communication, Drugs

Tags: Advertising and promotion, efficacy, Office of Prescription Drug Promotion

Do Price Comparisons Affect How Safe Patients Think a Drug is? FDA Plans to Find Out By Alexander Gaffney, RAC - Published 03 April 2015

The US Food and Drug Administration (FDA) plans to study whether including pricing information on the label of a pharmaceutical product affects how consumers view the safety and efficacy of drug products, especially when comparisons are made between two drugs.

Categories: News, US, CDER, Advertising and Promotion, Biologics and biotechnology, Drugs, Labeling

Tags: Drug Advertising, Pharmaceutical Advertising, OPDP, Office of Prescription Drug Promotion, Price Comparisons in Drug Advertising

FDA's Advertising Regulators Cite Drug Company in First Warning of 2015 By Alexander Gaffney, RAC - Published 11 February 2015

For the first time this year, the US Food and Drug Administration's (FDA) pharmaceutical advertising watchdog, the Office of Prescription Drug Promotion (OPDP), has issued a warning to a company for allegedly trying to promote a product for uses for which it had not received FDA approval.

Categories: News, US, CDER, Advertising and Promotion, Drugs, Labeling

Tags: OPDP, Office of Prescription Drug Promotion

In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims By Alexander Gaffney, RAC - Published 06 November 2014

The US Food and Drug Administration's (FDA) drug advertising oversight division has sent a warning to a pharmaceutical company regarding materials used to promote a drug, saying the materials omitted "important risk information" and contained claims about the drug's superiority that did not hold up to the agency's close scrutiny.

Categories: News, US, CDER, Advertising and Promotion, Drugs

Tags: Untitled Letter, OPDP, Unsubstantiated Claims, Risk Information, Office of Prescription Drug Promotion

FDA Chides Gilead for Google Advertisement, but is the Company Entirely to Blame? By Alexander Gaffney, RAC - Published 08 July 2014

Less than a month after the US Food and Drug Administration (FDA) first unveiled its long-awaited social media guidance documents, the agency has chided Gilead Sciences for its misuse of a "text-limited" Internet platform covered by its guidance documents, Google Sitelinks.

Categories: News, US, CDER, Labeling

Tags: Google, Google Sitelinks, OPDP, Office of Prescription Drug Promotion, Untitled Letter, Gilead