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FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

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

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

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

FDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor

FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more

Net Neutrality Revisited in the Wake of the Court of Appeals' Decision in Verizon v. FCC

On January 14, 2014, the latest chapter of the net neutrality controversy closed when the U.S. Court of Appeals for the District of Columbia decided that the Federal Communications Commission (FCC) was statutorily authorized...more

Another Motion to Amend Denied in IPR Final Written Decision

While Patent Owners have finally succeeded in having claims survive an inter partes review proceeding, no Patent Owner has yet to find the magic formula that successfully navigates a motion to amend. In a Final Written...more

FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages

Two new FDA guidance documents can assist both conventional beverage and liquid dietary supplement manufacturers to avoid costly mischaracterization and enforcement action. The US Food and Drug Administration (FDA or...more

FDA Issues Draft Guidance Addressing Postmarket Submission Requirements for Internet-based Promotional Materials

On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for...more

Twice Bitten But Not Shy, The FCC Is Handed The DC Circuit’s Prescription for Internet Regulation

On Tuesday, January 14, 2014, the United States Court of Appeals for the D.C. Circuit struck down the FCC’s latest effort to mandate “net neutrality”– or promote internet “openness” – under the auspices of implementing the...more

5 Ways the FCC Could Respond to Invalidation of Its 'Net Neutrality' Rules

After the Net Neutrality decision, the FCC has a number of options, all of which could have an important impact on providers and users alike....more

D.C. Circuit Largely Invalidates Net Neutrality Rules: Analysis and Prospects

On Jan. 14, 2014, a D.C. Circuit panel struck down the portions of the FCC’s 2010 “Open Internet” (or “net neutrality”) rules that had banned blocking or discriminatory treatment of web sites or other online applications by...more

Appeals Court Strikes Down FCC's Net Neutrality Rules

On January 14, 2014, the U.S. Court of Appeals for the District of Columbia Circuit issued a long-awaited decision on the Federal Communications Commission's Open Internet Order. That Order required broadband Internet...more

FDA Issues Draft Guidance Relating to Social Media Promotion by Drug and Biologics Manufacturers

On January 13, 2014, the Food and Drug Administration (“FDA”) issued a draft guidance document outlining the circumstances under which a manufacturer of a prescription drug or biological product may be accountable for content...more

Industry Group To Weigh In On GMO Labeling Debate

With the rise in state legislative efforts to require labeling for foods produced using genetic engineering or “GMOs,” the Grocery Manufacturers Association (GMA) is poised to enter the labeling debate by working with federal...more

Will the Recent Scientific Attack on Vitamin Use Spawn a New Wave of False Advertising Litigation?

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

Consumer Protection Laws And Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...more

Mobile Medical Apps Guidance

Mobile health ("mHealth") application ("app") developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration ("FDA") published its...more

FDA Submits Final Guidance on Mobile Medical Apps

Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more

FDA Releases Final Guidance on the Regulation of Mobile Medical Applications

On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more

Employer Social Media Policies – Interview with Mitch Danzig, Member, Member, Mintz Levin [Video]

Mitch Danzig, Member of Mintz Levin's Employment, Labor & Benefits Practice, discusses the importance of having a social media policy that is structured in accordance with the recent NLRB rulings. ...more

Top Ten Laws Any Online Operation Should Know. A Quick Guide.

Below is a top ten pocket guide for the top ten laws any operation (social, e-commerce, IP/UGC driven, etc.) needs to be familiar with now and for the foreseeable future. Having this at the ready won’t necessarily make you...more

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the...more

Emails and Text Messages On Personal Devices Subject to Public Records Act - Judge’s Ruling Demonstrates Risk to Public Agencies;...

A Santa Clara County Superior Court judge recently ruled that emails and text messages concerning city business but stored on a public official’s personal device are subject to the Public Records Act (PRA). The PRA request at...more

FDA Emphasizes Patient-Specific Prescriptions

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more

Levick Weekly - March 1, 2013: The Libor Scandal; Prosecutors Have A New Plan

In This Issue: - The Food Safety Modernization Act - The LIBOR Scandal - Prosecutors Have a New Plan - Food Safety Compliance - A Hogan Lovells Roundtable - Lessons from the Oldest CEO Succession Plan on...more

2012 Year in Review: FDA OPDP Warning Letters and Untitled Letters

In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more

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