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Filtering on: "topics advertising and promotion"

Showing 1 – 25  of 107

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

FDA Warns Two Pharma Companies Over Misleading Ads By Zachary Brennan - Published 16 December 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent two warning letters earlier this week for misleading advertisements.

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

Tags: pharmaceutical advertising, warning letters

FDA Tells Sanofi and Celgene to Stop Airing Misleading TV Advertisements By Zachary Brennan - Published 14 December 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday called on Sanofi-aventis and Celgene to stop broadcasting two of their direct-to-consumer television advertisements due to their misleading nature.

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

Tags: Celgene, Sanofi-aventis, Otezla, Toujeo, diabetes

FDA Calls Out Unproven Claims of Unapproved Blood Device By Zachary Brennan - Published 28 November 2016

Earlier this month, the US Food and Drug Administration (FDA) released a letter sent to Dr. PRP America for claims made on its website for an unapproved medical device that the San Diego-based company claims can help concentrate and extract blood platelets, as well as adjust blood plasma levels.

Categories: News, US, CBER, Advertising and Promotion, Labeling, Medical Devices, Quality

Tags: Dr. PRP America, blood plasma levels, PRP Kit, centrifuge

Recent Trends in Prescription Drug Promotion Enforcement By Francis Nguyen, Colin Vechery - Published 17 November 2016

This article presents brief summaries of the 2016 enforcement letters, analyzes how different data cuts, groupings and correlations to relatable events can be constructed to explain different trends and introduces some key events along the enforcement letter timeline.

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

Using Twitter as an Intelligence Tool: 85 Accounts Worth Following By Zachary Brennan - Published 16 November 2016

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical device spaces, for investors, and even for the regulators themselves, Twitter is a great place to catch the day’s breaking news before the headlines are written.

Categories: News, Asia, Europe, US, Advertising and Promotion, Biologics and biotechnology, Business and Leadership, Communication, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Twitter, regulatory affairs, regulatory intelligence

FTC Plans Crackdown on Marketing Claims of OTC Homeopathic Drugs By Zachary Brennan - Published 15 November 2016

The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims.

Categories: News, US, FTC, Advertising and Promotion, Over the counter drugs, Due Diligence, Quality

Tags: drug marketing, OTC drugs, homeopathic drugs

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

Medical Device Manufacturer Pleads Guilty to Misbranding and Agrees to Pay $36M By Zachary Brennan - Published 11 November 2016

Pennsylvania-based medical device manufacturer Biocompatibles Inc., a BTG subsidiary, pleaded guilty earlier this week to misbranding its embolic device used to treat liver cancer, among other diseases, and will pay more than $36 million due its illegal conduct, the Justice Department (DOJ) said. 

Categories: News, US, DOJ, FDA, Advertising and Promotion, Crisis management, Government affairs, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: Biocompatibles, misbranded medical devices, drug delivery, chemotherapy, LC Bead, BTG

FDA Offers Technical Rejection Criteria for Study Data By Zachary Brennan - Published 11 November 2016

For clinical and nonclinical studies starting after 17 December 2016, the US Food and Drug Administration (FDA) is requiring the use of data standards listed in the FDA Data Standards Catalog for all new drug applications (NDAs), biologic license applications (BLAs) and abbreviated new drug applications (ANDAs).

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: eCTD, study data files submitted to FDA

RAPS Regulatory Convergence - 2016 Hot Topic Review By Sara Bobbit - Published 09 November 2016

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions covering innovation and technology, Zika, real world evidence, patient access to innovative medicines and recent developments in off-label promotion.

Categories: News, Japan, Europe, US, FDA, MHLW, PMDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Drugs, Labeling, Medical Devices, Research and development, Submission and registration

Tags: Regulatory Convergence, 2016 RAPS

Drug Marketing on Twitter: FDA to Study Space-Limited Communications By Michael Mezher - Published 07 November 2016

The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited.

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

Tags: Social media, Twitter, Google

FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments By Zachary Brennan - Published 04 November 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) earlier this week sent a letter to Rockville, MD-based Supernus Pharmaceuticals noting that one of its promotional videos makes false or misleading claims and/or representations about the risks associated with Oxtellar XR (oxcarbazepine).

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

Tags: OPDP, untitled letter, FDA warning for advertising

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

A Regulatory Experience of a Lifetime By Peter J. Isikwe - Published 26 October 2016

This article covers a unique regulatory experience in the pharmaceutical industry.

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

Drugmakers Criticize FDA’s Plan to Research Animation in DTC Drug Ads By Zachary Brennan - Published 24 October 2016

Do the mucous monsters or the little pink, intestine-like cartoon really help consumers learn more about new treatments? Or are these and other animated characters in direct-to-consumer (DTC) pharmaceutical ads just a ploy to grab your attention?

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

Tags: drug advertisements, animated drug ads, cartoons and pharmaceuticals

FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective By Alan Minsk, Kelley Nduom - Published 20 October 2016

Despite all of the public discussion about FDA's enforcement approach in the off-label promotional arena, the agency continues to take action against any perceived unlawful promotion. Recently, FDA issued Notice of Violation letters to drug companies for promoting their investigational new drugs as safe and effective.

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

Tags: Notice of Violation