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Pro Te: Solutio Vol. 8 No. 2

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s...more

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

ITC Section 337 Update – October 2015

ITC Proposes Extensive Changes To Rules For Adjudicating Section 337 Investigations – On September 24, 2015, the Commission published a Notice of Proposed Rulemaking in the Federal Register announcing proposed changes to its...more

FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require More Sleuthing

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more

OPM admits 5.6 million fingerprints stolen during breach

The Office of Personnel Management (OPM) reported yesterday that fingerprint data stolen during the breach of almost 22 million Americans’ data is estimated to be 5.6 million instead of the original estimate of 1.1 million....more

Drug and Device Companies May Soon Face Less Burdensome FDA Approval Process

On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more

ITC Section 337 Update – September 2015

Judge MaryJoan McNamara Appointed New Administrative Law Judge at U.S. International Trade Commission – On August 17, 2015, the ITC issued a news release announcing that Judge MaryJoan McNamara has been appointed as an ALJ....more

FDA Issues Draft Guidance and Proposed Rule on the Nonproprietary Naming of Biological Products

On August 28, 2015, FDA issued a draft guidance document and a proposed rule addressing the nonproprietary naming of biological products. Because nonproprietary naming can have substantial effects on the market for biosimilar...more

OPM data breach update–$133 million contract awarded to vendor

The Office of Personnel Management (OPM) and the Defense Department announced this week that a Portland, OR based vendor has been selected to assist with breach notification and credit assistance for the almost 22 million...more

The Federal Circuit's First AIA Reversal

Since the implementation of the inter partes review (IPR) by the America Invents Act on September 16, 2012, IPR proceedings have been viewed as putting one nail in the coffin for patents. In the first two and a half years of...more

Blog: “Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

Proposition 65: OEHHA to Consider Adding and Delisting Certain Chemicals of Concern

The Office of Environmental Health Hazard Assessment (“OEHHA”), which is responsible for determining the chemicals that are included on its list of chemicals known to be carcinogenic or to cause reproductive harm, thereby...more

What’s in a Name? That Which We Call a Biological Product…

The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). One of the most eagerly awaited guidance documents has been that on nonproprietary names to be...more

Biological/Biosimilar Nonproprietary Naming Guidance and Proposed Rule for Certain Proposed Nonproprietary Names for...

On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more

OPM Breach Update

In response to the massive OPM data breach, the government has been searching for a vendor to provide identity protection services for the almost 22 million individuals affected. Bids were due last week, and the chosen vendor...more

FAA Announces Crackdown on Unauthorized Drone Flights

The Federal Aviation Administration (FAA) recently announced on its website that it was stepping up enforcement actions against individuals and organizations that operate unmanned aircraft systems (UAS), commonly known as...more

UK’s First Ever Right To Be Forgotten Enforcement : Google In The Firing Line Again

The UK’s Information Commissioner’s Office (ICO) has made what appears to be its first “right to be forgotten” enforcement action against Google Inc. The ICO issued the notice on 18 August 2015, ordering Google to remove nine...more

FDA is “Keeping up with Kardashians’” Social Media Posts

On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the...more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

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