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Filtering on: "topics advertising and promotion"

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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

FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information By Zachary Brennan - Published 23 February 2017

Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion.

Categories: News, US, FDA, Advertising and Promotion

Tags: OPDP, Patient Medication Information, proposed rule

European Regulatory Roundup: EMA Recommends Approval of First Monoclonal Antibody Veterinary Medicine (23 February 2017) By Nick Paul Taylor - Published 23 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, EMA, MHRA, Advertising and Promotion, Biologics and biotechnology, Drugs, Veterinary products

Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup

FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials By Michael Mezher - Published 15 February 2017

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution.

Categories: News, US, CBER, Advertising and Promotion, Blood, Compliance, Drugs

Tags: Fenwal, Fresenius Kabi, InterSol, Amicus, Promotional Materials

PhRMA, Lilly and AbbVie Weigh FDA Plan to Study Twitter Drug Ads By Zachary Brennan - Published 30 January 2017

When the space of characters is limited, can a link to risk information be enough for drugmakers advertising their products on social media like Twitter? That’s the question the US Food and Drug Administration (FDA) asked last November and now industry is offering their opinions on the planned studies.

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

Tags: Twitter drug ads, pharmaceutical advertisements, FDA and pharma ads

Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications By Zachary Brennan - Published 18 January 2017

When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public, be considered in violation of the law or US Food and Drug Administration (FDA) regulations?

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Labeling, Regulatory intelligence, Regulatory strategy

Tags: off-label drug communications, off-label marketing, First Amendment and pharmaceuticals, FDA guidance

FDA, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl By Zachary Brennan - Published 09 January 2017

Galena Biopharma on Monday disclosed in an SEC filing that the US Attorney’s Office for the District of New Jersey and the US Department of Justice (DOJ) are pursuing a criminal investigation, in addition to a previously announced civil investigation, related to the marketing and promotion of its deadly opioid Abstral (fentanyl), which the company sold for $8 million upfront in 2015.

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

Tags: Galena, DOJ, Abstral, fentanyl marketing

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