Search Results for DTC

Showing 1 – 25  of 28

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

Regulating Precision Medicine: Capacity vs. Overreach By Zachary Brennan - Published 05 May 2016

As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine.

Categories: News, Oceania, US, FDA, Biologics and biotechnology, Combination products, Drugs, Ethics, Government affairs

Tags: precision medicine, regulating DTC genomic tests, 23andMe

DTC Drug Advertising: FDA to Launch First Public Survey Since 2002 By Zachary Brennan - Published 26 February 2016

Direct-to-consumer (DTC) advertising for pharmaceuticals has been a hot topic recently as federal and state officials have questioned their utility, particularly as the US and New Zealand are the only two countries in the world that have them. Now, the US Food and Drug Administration (FDA) is looking to survey patients about their experiences with DTC drug ads.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Drugs, Regulatory strategy, Research and development

Tags: DTC pharmaceutical advertising, direct-to-consumer advertising, pharmaceutical ads, drug ads

FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid By Zachary Brennan - Published 18 November 2015

The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid.

Categories: News, US, FDA, Advertising and Promotion, Distribution, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Harmonyx, DTC genetic tests, FDA, CLIA, CAP, Rite Aid

AMA Calls to Ban DTC Advertising for Drugs, Medical Devices By Zachary Brennan - Published 17 November 2015

Physicians at the American Medical Association (AMA) on Tuesday called to ban direct-to-consumer (DTC) advertising for drugs and devices because of the negative impact of the commercially driven promotions.

Categories: News, US, FDA, Advertising and Promotion, Business and Leadership, Government affairs, Postmarket surveillance, Regulatory strategy, Research and development

Tags: AMA, drug pricing, DTC ads, pharmaceutical advertising, medical device advertising

FDA Warns Three Companies Over DTC Genetic Tests By Michael Mezher - Published 09 November 2015

Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests.

Categories: News, US, CDRH, Compliance, In vitro diagnostics, Medical Devices

Tags: Direct-to-consumer, DTC, Genetic tests, Laboratory Developed Tests, LDT, LDTs, DNA4Life, DNA-CardioCheck, Interleukin Genetics

FDA to Study Whether Consumers Can Take More Complicated Info in Pharma TV Ads By Zachary Brennan - Published 09 October 2015

As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads.

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

Tags: DTC television ads, pharmaceutical advertising, FDA research, DTC pharma ads

What Did You Say? FDA Plans Study on How Hearing Loss Affects Drug Ad Understanding By Alexander Gaffney, RAC - Published 24 June 2015

The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising.

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

Tags: DTC, Direct-to-Consumer Advertising, Study, Hearing, Elderly

FDA Calls for Changes to Drug Advertising in Hopes of Increasing Patient Understanding By Alexander Gaffney, RAC - Published 06 February 2015

The pharmaceutical advertising you see in magazines and newspapers will soon include less information in the hopes of better conveying what the actual risk of the drug is, the US Food and Drug Administration (FDA) announced today.

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

Tags: DTC Advertising, FDA Regulation of Advertising, Pharmaceutical Advertising, Drug Advertising, Guidance, Draft Guidance, OPDP

FDA Drug Advertising Study Tracker By Alexander Gaffney, RAC - Published 12 January 2015

The US Food and Drug Administration (FDA) frequently studies consumer behavior, particularly as it relates to how members of the public (and medical professionals) understand pharmaceutical advertising. Our FDA Drug Advertising Study Tracker keeps tabs on these studies and explains what they're trying to accomplish in plain terms.

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

Tags: Direct-to-Consumer Drug Advertising, DTC Drug Advertising, FDA Regulation of Drug Advertising, FDA Studies

FDA Considers Allowing Drug Companies to Drop Some Warnings in TV Commercials By Alexander Gaffney, RAC - Published 12 January 2015

The US Food and Drug Administration (FDA) has announced its plans to study whether consumers would benefit if direct-to-consumer television advertising contained a shorter list of major side effects instead of the now-lengthy list of nearly all of them.

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

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

Does Your Spouse Affect How you Perceive Drug Safety? An FDA Study Aims to Find out By Alexander Gaffney, RAC - Published 13 November 2014

The US Food and Drug Administration (FDA) has announced another proposed study of consumers who watch drug advertising on TV—the second this week—this time trying to assess how spouses influence how consumers understand a drug's benefits and risks.

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

Tags: DTC Advertising, OPDP, Study, Drug Advertising, Spouse

Barraged by Drug Ads? FDA Wants to Know How That Makes You Feel—About the Drug By Alexander Gaffney, RAC - Published 10 November 2014

There's no shortage of pharmaceutical advertising on US television stations. Watch a TV show for long enough, and chances are good you might even see the same drug ad several times. Now the US Food and Drug Administration (FDA) says it's interested in studying whether consumers who view the same drug ad multiple times perceive the safety or efficacy of the advertised drug differently than those who view it only once.

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

Tags: DTC Advertising, Study, FDA Study on DTC Advertising

Do Distractions in Drug Ads Put Consumers at Risk? FDA Study to Find out By Alexander Gaffney, RAC - Published 12 September 2014

The US Food and Drug Administration (FDA) has received approval to go forward with a proposed study to study the effects of "distractions" in direct-to-consumer drug advertising, which it hypothesizes may reduce consumers' ability to remember risk information about a product.

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

Tags: DTC Advertising, Direct-to-Consumer Drug Advertising, Pharmaceutical Advertising, Distractions in Drug Advertisements

Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out By Alexander Gaffney, RAC - Published 18 July 2014

How do teenagers and young adults interpret messages contained in direct-to-consumer pharmaceutical advertisements? The US Food and Drug Administration (FDA) wants to know, and is now moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising.

Categories: News, US, CDER, Drugs

Tags: Study, DTC Advertising, Teenagers, Young Adults, Adolescents

Do 'Distractions' in DTC Advertising Affect Patient Risk Perception? FDA Wants to Know By Alexander Gaffney, RAC - Published 27 May 2014

The US Food and Drug Administration (FDA) has put the finishing touches on a proposed eye-tracking study intended to assess how patients assess the benefits and risks of direct-to-consumer (DTC) drug advertising when subject to on-screen "distractions."

Categories: News, US, CDER, Drugs

Tags: DTC, Advertising, Study, Eye-Tracking Study, Obesity, Distractions

FDA Expresses Interest in Comparative Price of Drugs (But not in the way you Think) By Alexander Gaffney, RAC - Published 06 May 2014

Categories: US, FDA

Tags: Cost Comparison, Drug Cost, Drug Pricing, DTC Advertising, Latest News, marketing, advertising

FDA's Proposal to Cut Down on Risks Listed in Drug Ads Wins Praise From Drug Companies By Alexander Gaffney, RAC - Published 24 April 2014

Categories: US, FDA

Tags: Proposed Study, DTC Advertising, Major Statement, Latest News, advertising, promotion

FDA Seeks to Determine how Consumers Find Health Information Online, Perceive Benefit-Risk By Alexander Gaffney, RF News Editor - Published 24 July 2013

Categories: US, FDA

Tags: Benefit-risk, Benefit, DTC, Latest News, marketing, social media, risk

Opening the Black Box: FDA Plans Study of DTC Advertising and Use of Composite Scores By Alexander Gaffney, RF News Editor - Published 13 May 2013

Categories: US, FDA

Tags: DTC, study

FDA Gets Go-Ahead for Study of DTC Advertising and Social Media By Alexander Gaffney, RF News Editor - Published 18 April 2013

Categories: US, FDA

Tags: DTC, Latest News, advertising, promotion, social media

Regulators to Study use of Composite Scores in Drug Advertising By Alexander Gaffney - Published 22 August 2012

Categories: FDA

Tags: Composite Score, DTC, Latest News, marketing, advertising, study

US Regulators Move Ahead With Planned Study on DTC Marketing By Alexander Gaffney - Published 27 June 2012

Categories: FDA

Tags: Offers, OTC, DTC, Consumers, Latest News, advertising, promotion, study

PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights By Alexander Gaffney - Published 21 May 2012

Categories: FDA

Tags: Narrowly Tailored, Free Speech, First Amendment, DTC, PhRMA, Latest News, draft guidance, advertising, guidance

FDA Reopens Comment Period on DTC Advertising Regulations By Alexander Gaffney - Published 22 March 2012

Categories: FDA

Tags: Major Statement, DTC, Latest News, marketing, advertising, study