Search Results for Promotion

Showing 1 – 25  of 53

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

Conducting a Successful Advertising and Promotion Review of Restricted Medical Devices By Lynn Deutsch - Published 25 September 2017

This article provides insight for regulatory professionals regarding developing a successful advertising and promotional review of restricted medical devices. It demonstrates how medical device manufacturers and pharmaceutical companies can improve communication and collaboration between regulatory and marketing to streamline and improve the compliance review process for promotional materials and achieve an effective marketing strategy.

Categories: Features, US, FDA, Advertising and Promotion, Medical Devices

Tags: Product Review Committee, Promotion,

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

PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion By Zachary Brennan - Published 16 August 2017

The pharmaceutical industry lobbying group known as the Pharmaceutical Research and Manufacturers of America (PhRMA) is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory strategy

Tags: PhRMA, drug advertising and promotion, FDA research

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

Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances By Zachary Brennan - Published 21 April 2017

With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Labeling, Medical Devices

Tags: medical product communications, off-label promotion, payer communications

FDA to Further Study Deceptive Drug Advertising By Michael Mezher - Published 04 January 2017

The US Food and Drug Administration (FDA) says it plans to study how well consumers and healthcare professionals are able to identify deceptive or misleading information in drug advertisements.

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

Tags: Deceptive promotion, Study

FDA Questions Need for Looser Off-Label Promotion Restrictions By Michael Mezher - Published 14 November 2016

Officials from the US Food and Drug Administration (FDA) last week questioned industry arguments for looser regulations on off-label promotion for drugs and devices at a two-day public hearing at FDA's White Oak campus.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Communication, Drugs, Medical Devices

Tags: Off-label promotion

Off-Label Promotion: Researchers Call on Courts to Reject Caronia By Michael Mezher - Published 03 November 2016

Two researchers are calling for the US Food and Drug Administration (FDA) to take a stand against off-label promotion in light of recent legal proceedings, and urge the courts to reject the precedent set in United States v. Caronia.

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

Tags: Caronia, Amarin, Pacira, Aaron Kesselheim, Christopher Robertson, Off-label promotion

Do Recent First Amendment Court Developments Deal a Blow to the Government? By Alan Minsk, Kelley Nduom - Published 05 October 2016

This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications.

Categories: Features, US, FDA, Advertising and Promotion, Communication, Drugs, Government affairs

Tags: Amarin, Pacira, Vascular Solutions, First Amendment, Off-label promotion

Regulatory Advertising and Promotion: Exploring the Past and Present to Understand the Future By Richard Lem, PharmD, Irene Darras, PharmD, Kate Ho, PharmD - Published 27 September 2016

This article provides a chronological overview of legislative milestones shaping the landscape of regulatory advertising and promotion. It reviews standards for prescription drug promotion and summarizes important cases involving off-label promotion with the purpose of showing that while interpretation for what is considered truthful and not misleading has been changing, regulations defining them have not changed.

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

Tags: Off-Label Promotion, Amarin, Pacira, Vascular Solutions

MHRA Raises Concerns Over Improper Biosimilar Marketing By Zachary Brennan - Published 02 August 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway.

Categories: News, Europe, MHRA, Advertising and Promotion, Biologics and biotechnology, Crisis management, Government affairs

Tags: Remsima, Remicade, biosimilar, drug promotion, ABPI, PMCPA

FDA, Amarin Propose to Settle Landmark Off-Label Marketing Case By Zachary Brennan - Published 08 March 2016

Amarin and the US Food and Drug Administration (FDA) late Tuesday announced the proposed settlement terms of a major First Amendment lawsuit over the off-label promotion of a drug.

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

Tags: Amarin, Caronia, Vascular Solutions, off-label promotion, FDA litigation

Amarin, FDA Seek One More Month to Hash Out Off-Label Promotion Settlement By Zachary Brennan - Published 18 February 2016

Biopharma company Amarin and the US Food and Drug Administration (FDA) have jointly requested one more month to try to settle a landmark off-label promotion lawsuit.

Categories: News, US, FDA, Advertising and Promotion, Drugs, Ethics, Government affairs, Labeling

Tags: Amarin, Vascepa, off-label promotion

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

Case Study: Regulatory Advertising and Promotion From a Fellow’s Perspective By John Riehl - Published 16 October 2015

This article discusses three components of Purdue University’s Regulatory Pharmaceutical Fellowship from a current fellow’s perspective followed by a candid interview.

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

Tags: drug advertising and promotion, FDA, Purdue University, Johnson & Johnson, Eli Lilly, regulatory pharmaceutical fellowship

Evolution of Advertising and Promotion Review Systems By Bill Robinson, Linda Pollitz - Published 15 October 2015

This article addresses the evolution of review systems used for advertising and promotion materials.

Categories: Features, Advertising and Promotion

Tags: Promotion Review Systems, Medical-Legal-Regulatory Review Committee, MLR, Promotional Review Committee, PRC

Prescription Drug Advertising Versus Non-Advertising Promotion in China: Contrasting Regulation By Denise Sanchez - Published 13 October 2015

This article discusses the contrasts between regulatory oversight of prescription drug advertising and non-advertising promotion in China.

Categories: Features, China, CFDA, Advertising and Promotion, Drugs, Due Diligence, Ethics

Tags: CFDA, China FDA, drug advertising, non-advertising promotion

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

Stories From the Promotional Review Battlefront By Jill Charbonneau - Published 07 October 2015

This article shares advertising and promotion experiences and presents strategies to improve a team's performance.

Categories: Features, FDA, Advertising and Promotion, Business and Leadership, Communication

Tags: Advertising and Promotion, Promotional Review Committee, PRC

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

Court Sides With Amarin in Off-Label Suit By Michael Mezher - Published 10 August 2015

On Friday, a New York Court sided with biopharmaceuticals maker Amarin in a suit against the US Food and Drug Administration (FDA) involving the off-label promotion of Vascepa.

Categories: News, US, FDA, Advertising and Promotion, Clinical, Drugs, Government affairs

Tags: Off-label promotion, Amarin, Vascepa

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

Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event By Zachary Brousseau - Published 29 May 2015

As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. RAPS’ virtual event Advertising, Promotion and Labeling: the US Regulated Environment will bring together experts to offer their advice.

Categories: HTML, Articles, Under RAPS, RAPS Events, US, FDA, FTC, RAPS, Advertising and Promotion, Compliance, Labeling

Tags: advertising, promotion, labeling, social media, social media regulation, FDA, FTC