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FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how...more

Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device...

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance...more

FDA Issues Draft Guidance on Promotion on Internet and Social Media Platforms

On June 17, 2014, the FDA issued long-awaited draft guidance documents addressing two challenges related to use of social media to communicate about FDA regulated products: dissemination of information in character-limited...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

TCPA Plaintiff Loses—Express Consent Given to Health Insurance Plan Trumps Claim

In a recent case in the U.S. District Court for the Eastern District of Missouri, the district court held that the plaintiff’s Telephone Consumer Protection Act (“TCPA”) claim should be dismissed. The court ruled that the...more

The New Normal: Big Data Comes of Age

On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing...more

The regulation of cosmetic interventions in the UK: toothless rhetoric or industry overhaul?

This Reed Smith client alert looks at the UK government’s response to the independent review of the regulation of cosmetic interventions in the UK. The key issues In recent years, cosmetic procedures have become widely...more

FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more

FTC Settles Case With Medical Transcription Company

The Federal Trade Commission (FTC) recently announced that it had settled its data privacy case against medical transcription firm GMR Transcription Services, Inc. (GMR) following allegations that GMR had failed to adequately...more

FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers

Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of...more

Some Things Better Left Unshared: Social Media and Medical Identity Theft

The Washington Post recently published an article reminding individuals not to tweet or otherwise share information concerning their medical conditions on social media, warning that disclosing such information publicly “is...more

Advertising Law - Feb 13, 2014

FTC Drives Car-Related False Ad Suit to Settlement - The Federal Trade Commission recently settled charges with Nissan North America and its advertising agency over deceptive advertising for the Nissan Frontier pickup...more

In with the New, Part III: 2014 Privacy, Advertising and Digital Media Predictions

Boston-based litigation partner Matt Turnell shares his predictions about class action litigation under the Telephone Consumer Protection Act (TCPA) and Electronic Communications Privacy Act (ECPA) in 2014 and Boston-based...more

U.S. Privacy and Data Protection: 2013 Year in Review and a Look Ahead to 2014

In Boston, we celebrated Data Privacy Day (January 28) by presenting “U.S. Privacy and Data Protection: 2013 Year In Review and a Prediction of What’s to Come in 2014” for participants in an IAPP KnowledgeNet. Our panel of...more

Google’s Breach of Canadian Privacy Rules

In a recent decision released by the Canadian Privacy Commissioner (PIPEDA Report of Findings #2014-001), the commissioner investigated a complaint that Google pitched ads to an individual based on medical information that he...more

Oh Canada! Google Settles Health-Related Behavioral Advertising Claims

The Office of the Privacy Commissioner of Canada (OPC) announced on January 15, 2013, that it reached a settlement with Google over the use of health information in behavioral advertising. The case involving a complaint that...more

Is Using Health Information For Interest-Based Advertising Really Off-Limits?

As was widely reported, on January 15, 2013, the Office of the Privacy Commissioner of Canada (OPC) issued a Report of Findings regarding interest-based advertising or online behavioural advertising through Google’s AdSense...more

23andMe Named in Class Action Lawsuit

Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more

The Online Marketer’s Guide To Privacy

I’ve hesitated to write this post because the law is always changing and you can’t cover it all in one blog post (thank goodness for linking). I did a presentation to the Houston Interactive Marketing Association this week...more

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