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MHRA Publishes Draft Guidance on GxP Data Integrity

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published for public consultation a draft guidance on GxP Data Integrity which includes definitions of key terms. The draft Guidance applies to both paper and electronic data in all areas of GxP (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and

New Guidance Makes Clear that FDA Is Focused on Insanitary Conditions at Pharmacy Compounders

Today, FDA published yet another draft guidance targeting drug compounders, entitled Insanitary Conditions at Compounding Facilities (the Draft Guidance). Notably, it makes clear to pharmacy compounders that although they may be exempt from FDA’s current Good Manufacturing Practice (cGMP) requirements, they are not exempt from FDA’s prohibition on insanitary conditions. And FDA, along with state

New Bill on Telemedicine is Submitted to the Russian Parliament

On 30 May 2016 a bill on telemedicine (the “Bill“) was submitted to the lower house of the Russian Parliament for consideration introducing a new form of provision of medical services in Russia – telemedicine (Bill No. 1085466-6 “On Introducing Amendments to the Federal Law “On the Fundamentals of Public Health Protection in the Russian Federation”

Court of Appeals Upholds FCC’s Open Internet Order

In a major victory for the Federal Communications Commission’s democratic majority, the U.S. Court of Appeals for the D.C. Circuit upheld the FCC’s 2015 Open Internet Order on June 14, 2016.  The 2-1 decision by the D.C. Circuit Court of Appeals likely is not the last word on net neutrality because broadband service providers will

Quiet Down? US Examines Whether Too Much Noise from Modern-Day Products Might Pose a Risk to Wireless Communications

The Federal Communications Commission (“FCC”) is seeking updated information on how the increased adoption of radiofrequency energy-emitting devices is affecting the level of unwanted RF energy emitted from man-made sources (the “spectrum noise floor”).[1]  The FCC’s Technological Advisory Council (“TAC”) has launched a technical inquiry to study changes to the spectrum noise floor over the

De-Regulating the Sharing Economy: European Commission Publishes Guidelines to Promote National Harmonization

Back in October 2015, as part of its Single Market Strategy, the European Commission declared that it would develop an agenda to encourage consumers, businesses and public authorities to engage confidently in the sharing economy (also known as the “collaborative economy”), where private individuals provide on-demand services to other people, without intermediaries. This peer-to-peer model

Federal Court Determines that Patient Has Liberty Interest in Receiving Investigational Drug

On May 17, 2016, a federal judge, citing arbitrary and capricious decisionmaking by FDA and notice-based due process concerns, granted a plaintiff’s emergency motion for a temporary restraining order against FDA, thereby preventing FDA from putting a clinical drug trial on hold with respect to the plaintiff, Eugene “Neil” Fachon. Fachon, a 20-year old student

Big News: Small UAS Rule at OIRA for Final Review

In a major new development, the FAA has sent the Small UAS NPRM to the White House for a final interagency review.  This means that a final small UAS rule is coming soon – and that NOW is the last opportunity to influence the rule before it is released. Before any significant regulatory action takes

FDA Issues Data Integrity Guidance, Providing Views on Expected Data Integrity Controls and Oversight

Earlier today, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance addressing a topic affecting the entire pharmaceutical industry—Data Integrity.  The guidance, entitled Data Integrity and Compliance with CGMP, Guidance for Industry (Draft Guidance), and styled as a series of questions and answers, is the first guidance document FDA has issued specifically concentrating

EMA Begins EudraVigilance Training Courses

The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA).

NIH and FDA Announce Release of Draft Clinical Trial Protocol Template; Call for Comments by April 17, 2016

The National Institutes of Health (NIH) and Food and Drug Administration (FDA) announced on March 17, 2016, their co-development of a draft clinical trial protocol template for use by NIH-funded investigators.  The template is meant for use in writing phase 2 or 3 clinical trial protocols where Investigational New Drug application (IND) or Investigational Device

FDA Notifies Applicants of Intent to Require Sweeping Changes to Labeling for IR Opioid Analgesics and Entire Class of Prescription Opioids

FDA has announced its intent to require new class-wide labeling requirements for immediate-release (IR) opioid pain medications including new black and other safety warnings.  The enhanced warnings are intended “to inform prescribers and patients of additional risks related to opioid use.”  FDA, News Release (March 22, 2016) (hereinafter, “News Release”).  FDA further announced its intent

FCC Imposes $1.84 Million TCPA Penalty for Fax Advertisements

The Federal Communications Commission (“FCC”) recently imposed a $1.84 million penalty for sending unsolicited fax advertisements.  According to the agency’s forfeiture order, Scott Malcolm, DSM Supply, LLC and Somaticare, LLC (the “DSM Parties”) sent 115 unsolicited fax advertisements to 26 consumers, primarily health care practitioners, in violation of the FCC’s Telephone Consumer Protection Act (“TCPA”)

FCC Circulates Privacy Rulemaking and Announces Commission Vote

On Thursday, Federal Communications Commission (“FCC”) Chairman Tom Wheeler circulated a highly anticipated broadband data privacy and security Notice of Proposed Rulemaking (“NPRM”) to the other Commissioners, slating the proposals for a full Commission vote at the agency’s March 31 Open Meeting.  The rules would apply to internet service providers (“ISPs”), but organizations throughout the

It’s Settled … At Least Somewhat: Settlement of the First Amendment Case Amarin Pharma v. FDA

The U.S. Food and Drug Administration (FDA) and Amarin Pharma, Inc. (Amarin) have released a stipulation and settlement order that would resolve all causes of action raised in Amarin’s successful lawsuit against the agency, with both parties waiving the right to appeal. On August 7, 2015, the U.S. District Court for the Southern District of

Privacy, Security, and IoT Prominent Themes at Silicon Flatirons DBM Conference

On January 31, 2016, the Silicon Flatirons Center for Law, Technology, and Entrepreneurship at the University of Colorado hosted its annual Digital Broadband Migration Symposium. The theme of this year’s conference was “The Evolving Industry Structure of the Digital Broadband Landscape.” The two-day conference brought together an array of leaders from government, academia, and industry to examine the role of regulatory oversight, antitrust law, and intellectual property policy in regulating industry structure and to discuss what policy reforms may be appropriate for the constantly changing digital broadband environment.

FCC Harmonizes Pole Attachment Rates

The Federal Communications Commission’s (“FCC”) decision to further harmonize the rates that telecommunications and cable companies pay to attach to “utility” poles was recently published in the Federal Register.  Federal law limits how much pole owners can charge attachers by tying monthly rents to the cost of constructing and maintaining the poles.  These poles are

Supreme Court Decision in Gomez Shifts Attention Back to FCC TCPA Petitions

In January, the United States Supreme Court issued a long-awaited ruling in Campbell-Ewald Co. v. Gomez, 577 U.S. __ (2016), a significant case for companies defending against consumer and other class actions, including those based on the Telephone Consumer Protection Act (TCPA) – as well as for contractors working on behalf of the federal government.

G2 LNG Initiates Pre-Filing Process with FERC

G2 LNG, LLC (G2 LNG) has requested that the Federal Energy Regulatory Commission (FERC) initiate its NEPA pre-filing review process for G2 LNG’s proposed Calcasieu River LNG project in Cameron Parish, La. The planned facility would export up to 14 million metric tonnes of liquefied natural gas (LNG) annually. G2 LNG will site, construct, own, and

China proposes new cyber security rules for insurance industry

On 9 October 2015, the China Insurance Regulatory Commission (“CIRC“) issued draft Supervisory Rules for Adoption of Information Technology by Insurance Institutions (“Draft Insurance IT Rules“) for public comment. The public comment period will close on 31 October 2015. The Draft Insurance IT Rules have been issued to replace the 2009 (Pilot) Guidance on Administration

FTC Closes PayPal Investigation Over Telemarketing Rule and User Agreement

The Federal Trade Commission (FTC) has released a copy of a letter that it sent to PayPal stating that the agency was closing an investigation into potential Telemarketing Sales Rule (TSR) violations by the company.  This release provides important insights on how companies can design their user agreements to avoid TSR violations. As background, PayPal

FCC Releases Waiver Order and Two Declaratory Rulings on TCPA Fax Rules

Today the Federal Communications Commission (“FCC”) released three Orders relating to the fax requirements under the Telephone Consumer Protection Act (the “TCPA”). Under the TCPA, it is unlawful for a person to use a fax machine, computer, or other device to send an unsolicited advertisement to a telephone fax machine unless there is an established