FCPA Compliance and Ethics Report-Episode 3-Interview with Marie Patterson, Vice President of Marketing for Hiperos
What you need to know about Canada's new Anti-Spam Law (CASL)
Why Ending FCC Blackout Rules May Be Broadcast TV's Demise
FCC Proposes New Rules On Local Wireless Siting
Data Center Networks – Interview with Jeff Moerdler, Member, Mintz Levin
What to expect from FCC Post-Governement Shutdown
Employer Social Media Policies – Interview with Mitch Danzig, Member, Member, Mintz Levin
Jason Maloni on Data Security
JOBS Act Implementation Regulations
Ernest DelBuono on Aviation
Jack Deschauer on Government Investigations
Polsinelli Podcast - Public Policy Issues in 2013
Condo Adviser: Condominium Rules and Enforcement
Condo Adviser: What is 'FHA approved,' exactly?
Condo Owners and Dealing with Uncooperative Management Companies
Reserve Funds: Purposes and Common Mistakes
Instapundit: America's IP Laws Need to be "Pruned Back"
Polsinelli Podcast - Social Media at Work - What's Allowed and What Isn't?
Release of new book on the 'Best Practices Under the FCPA and Bribery Act"
[Legal Perspective] When Is It NOT Okay to Delete Your Social Media Account?
The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more
The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more
On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...more
On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more
On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more
Apple’s apps store lists close to a 100,000 health apps. Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare...more
On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. This...more
Wearable technology issues relating to the potential qualification of such products as a medical devices have become popular on the press following the presentation of the first smartphone with a heart rate sensor, quickly...more
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
In January 2014, the US Food and Drug Administration (FDA) gave the pharmaceutical industry another glimpse of its thinking on social media marketing. The agency’s draft guidance, titled “Fulfilling Regulatory Requirements...more
The way that we communicate has changed. Technology and social media have altered how we keep in touch with friends and family. Whether it is a text message that you will be late for dinner, a Tweet about breaking news, or an...more
On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.” The draft guidance,...more
FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more
On March 3, 2014, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (“Revised Draft...more
On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more
On February 28, 2014, the Food and Drug Administration (“FDA”) released a revised draft guidance for industry entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“Revised...more
As part of existing FDA postmarketing reporting requirements, manufacturers, packers, and distributors that are FDA applicants or that act on behalf of FDA applicants (for simplicity, “Applicants”) are required to submit all...more
In 2013, FDA’s Center for Devices and Radiological Health (CDRH) made publicly available on its website a total of 22 promotion and marketing-related enforcement letters to device manufacturers. Of the 22 enforcement letters,...more
Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age.
On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing...more
The question every false claims defendant must face is whether to pursue litigation or simply concede and settle. While many shy away from litigation, opting for an expensive but certain resolution, for Johnson & Johnson and...more
What is the “country of origin” for the drugs you manufacture? This question arises every time a pharmaceutical company labels a drug, imports it, exports it, markets it, or sells it to the U.S. government. Unfortunately, the...more
On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for...more
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
Two whistleblowers used the qui tam provisions of the False Claims Act (FCA) to file lawsuits against biotechnology company Genzyme Corp. for teaching doctors and other medical staff how to create a "slurry" version of its...more
For centuries, we’ve ingested magic elixirs in pill and syrupy forms to cure whatever ails us and to ward off future illness. Hard scientific evidence of efficacy may have been lacking for these nostrums, but lingering...more
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