Search Results for

Filtering on: "topics advertising and promotion"

Showing 1 – 25  of 130

FDA Warns Imprimis for False and Misleading Website and Twitter Promotions By Zachary Brennan - Published 16 January 2018

The US Food and Drug Administration (FDA) late last month sent a warning letter to San Diego-based Imprimis Pharmaceuticals for false and misleading claims made on the company’s website and Twitter account, among other violations.

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

Tags: Imprimis, Twitter, FDA warning letters

FTC Settles Complaint Over Deceptive Marketing of Unapproved Cancer Products By Michael Mezher - Published 12 January 2018

The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products.

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

Tags: FTC, Federal Trade Commission, CellMark

OPDP Letters: FDA Closes Out 2017 With Record Low By Michael Mezher - Published 03 January 2018

In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP).

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

Tags: OPDP, Prescription Drug Promotion, Warning Letter

Medtronic Settles Deceptive Advertising Lawsuit for $12M By Zachary Brennan - Published 13 December 2017

State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multistate settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse.

Categories: News, US, Advertising and Promotion, Medical Devices

Tags: Medtronic, Infuse, deceptive marketing

FDA Finalizes Guidance on Promotional Drug Labeling and Ads By Zachary Brennan - Published 11 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.

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

Tags: drug labeling, promotional and advertising guidance FDA, deceptive pharma ads

OPDP Issues Third Warning of 2017 By Zachary Brennan - Published 28 November 2017

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) this month issued its third warning or untitled letter of the year to Kentucky-based Magna Pharmaceuticals because its webpage and panels from a conference exhibit made false or misleading claims about the risks associated with and efficacy of its insomnia treatment Zolpimist (zolpidem tartrate).

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

Tags: untitled letter, warning letter, OPDP

Stakeholders Weigh FDA Proposal to Limit Risk Info in DTC Advertisements By Zachary Brennan - Published 27 November 2017

Industry and pharmacy groups generally support the US Food and Drug Administration's (FDA) proposal to limit the amount of risk information presented in pharmaceutical direct-to-consumer (DTC) advertisements, though others have criticized the plan and research backing it as flawed.

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

Tags: DTC drug advertisements, risk information in drug ads

Nutrition, Health and Disease Management, Advertising, Promotion, Labeling and a Preview of November's MDR, IVDR Update By Gloria Hall - Published 07 November 2017

Feature articles over the past several weeks covered two main themes: nutrition, health and disease management and advertising, promotion, labeling.

Categories: Features, Advertising and Promotion, Labeling, Nutritional and dietary supplements

Tags: Regulatory Focus, Feature Articles, Editorial

UK Industry Group Sees More Complaints Against Pharma Members in 2016 By Michael Mezher - Published 30 October 2017

The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the Association of the British Pharmaceutical Industry's (ABPI) code of practice, says it saw more complaints about drugmakers' promotional materials and activities in 2016 than in the previous year.

Categories: News, Europe, Advertising and Promotion, Drugs

Tags: PMCPA, ABPI, ABPI Code

The Life and Times of a Promotional Claims Compendium By Rebecca Rivera Torres, MS, RD, CSSD - Published 30 October 2017

This article discusses developing a "promotional claims compendium" to review pharmaceutical marketing materials. It highlights the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization.

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

Tags: Promotional Materials, Promotional Claims, Brand Book

DTC Drug Ads: New Study Finds Perception of Risks Diluted by Lengthy Side Effects List By Michael Mezher - Published 11 October 2017

A study on direct-to-consumer (DTC) drug advertising published Monday in Nature Human Behavior finds that consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed.

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

Tags: Direct-to-Consumer, Drug Advertising, Side Effects, Risk

Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods By Gloria Hall - Published 04 October 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in October.

Categories: Features, Canada, Europe, US, FDA, Health Canada, MHRA, NICE, Advertising and Promotion, Labeling, Nutritional and dietary supplements, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

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,

Galena Biopharma Settles Opioid Kickback Allegations By Michael Mezher - Published 08 September 2017

Galena Biopharma has agreed to pay more than $7 million to settle allegations made in a whistleblower suit that the company gave kickbacks to doctors to boost prescriptions for the company's sublingual fentanyl drug Abstral.

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

Tags: Abstral, Galena

Novo Nordisk Pays $58M to Settle REMS Allegations By Michael Mezher - Published 06 September 2017

Danish drugmaker Novo Nordisk on Tuesday agreed to pay $58 million to settle allegations that the company failed to follow the risk evaluation and mitigation strategy (REMS) for its blockbuster diabetes drug Victoza (liraglutide).

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

Tags: Novo Nordisk, Victoza, REMS

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

FDA Weighs Limited Risk Info in DTC Ads By Michael Mezher - Published 21 August 2017

The US Food and Drug Administration (FDA) on Friday announced it is considering a new approach to presenting risk information in direct-to-consumer (DTC) television and radio ads that would allow drugmakers to limit the amount of risks presented.

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

Tags: Advertising, DTC, Risk, Major Statement

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

FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads By Michael Mezher - Published 07 August 2017

A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks.

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

Tags: Direct-to-Consumer, DTC, Drug Advertising, Risk, Fair Balance

Careers in Regulatory Advertising and Promotion By Dana Huettenmoser, PharmD - Published 19 July 2017

This article provides an overview of Regulatory Advertising and Promotion (RAP) as a career in the pharmaceutical industry and discusses topics such as potential avenues for starting a career in RAP, qualities required to be successful, and some general career advice, including information on post-PharmD RAP fellowships and the benefits to be gained from serving them.

Categories: Features, Advertising and Promotion, Career Development

Australia’s TGA to Take Over Regulation of Therapeutic Goods Advertising By Zachary Brennan - Published 07 July 2017

Beginning 1 July 2018, Australia’s Therapeutic Goods Administration (TGA) will be responsible for receiving and considering all complaints about drug and medical device advertisements directed at the public under what it calls "a simplified complaints system."

Categories: News, Oceania, TGA, Advertising and Promotion, Biologics and biotechnology, Drugs, Medical Devices

Tags: TGA, drug advertising Australia

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 Cracks Down on TV Ad for Prescription Weight Loss Drug By Zachary Brennan - Published 24 May 2017

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent its first untitled letter of 2017 to Orexigen Therapeutics for a television ad that created a misleading impression about the safety of the weight loss drug Contrave (naltrexone HCl and bupropion HCl).

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

Tags: OPDP, Contrave, untitled letter, drug advertisements, TV drug ads

House Bill Seeks to Expand Off-Label ‘Scientific Exchange’ Between Industry, Doctors By Zachary Brennan - Published 29 March 2017

While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians.

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

Tags: off-label communications, intended uses, scientific exchange, pharmaceutical policy