Administrative Agency Science, Computers & Technology

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On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more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

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

FDA Update: New guidance released on mobile medical devices, medical devices data systems

Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

UK Insurers Probed for Cyber Risk

The UK's Prudential Regulation Authority (PRA) has, this month, written to insurance companies in the UK to find out more about how they deal with the threat posed by cyber attacks and what mechanisms they have in place to...more

FDA Announces 2016 Medical Device Fees

The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval. The National Law...more

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

UK Report Assesses Workplace Exposure and Control Measures During the Manufacture and Handling of Engineered Nanomaterials

The United Kingdom’s Health and Safety Laboratory (HSL) of the Health and Safety Executive (HSE) prepared a report entitled Summary of work undertaken to assess workplace exposure and control measures during the manufacture...more

Zyga Receives 510(k) Clearance

Zyga Technology, Inc., a medical device company dedicated to the research, development, and commercialization of surgical solutions to treat conditions of the lumbar spine, recently announced that it has received 510(k)...more

FDA Issues Guidance to Streamline Review of 510(k) Submissions. A Clear Path Forward?

On August 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health released a new guidance document intended to provide applicants with clear and consistent guidance in the submission...more

AbbVie Requests Biosimilar Labeling Modification

On August 10, AbbVie, Inc. filed a supplement to its earlier filed Citizen Petition, levying another challenge to FDA’s implementation of the Biologics Price Competition and Innovation Act (BPCIA). This supplemental filing...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

Federal Circuit Upholds ITC Interpretation of § 337 to Cover Induced Infringement

Suprema, Inc. and Mentalix Inc. v. Int’l Trade Comm’n, Case No. 12-1170 (Fed. Cir. Aug. 10, 2015) (Reyna, J.) (O’Malley, Proust, Lourie, and Dyk JJ., dissenting). By way of background, appellee Suprema manufactures...more

Federal Court Rules on OPT Extension

On Wednesday, August 12, 2015, the US District Court for the District of Columbia ruled that the US Department of Homeland Security (“DHS”) did not follow required procedures when it promulgated regulations allowing for...more

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

Also In The News - Health Headlines - August 2015 #2

House Report Highlights Cybersecurity Concerns At The Department Of Health and Human Services – The U.S. House of Representatives Committee on Energy and Commerce released a report revealing that five operating divisions at...more

Blog: HHS OIG Approves Drug Company Program Providing Free Cancer Treatment Drugs

On Tuesday, the Health and Human Services (HHS) Office of Inspector General (OIG) issued an Advisory Opinion regarding a program to provide a 30-day supply of cancer drugs free of costs to patients who experience an insurance...more

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