Science, Computers & Technology Administrative Agency

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:
News & Analysis as of

Companies Appeal ECHA’s Requests for Information Concerning Nanoforms

The cases all concern silicic acid, aluminum sodium salt. The contested decisions were adopted December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each...more

DHS Chemical Facilities Take Note GAO Suggested Need For Enhanced Enforcement

The U.S. Government Accountability Office (GAO) has just issued a report on Critical Infrastructure Protection with a finding that Department of Homeland Security (DHS) action is needed to verify chemical facility information...more

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

Modernizing and Coordinating the Regulatory System of Biotechnology Products

On July 2, 2015, the U.S. Office of Science and Technology Policy (OSTP) of the Office of the President issued a memorandum to initiate a process to coordinate, update and modernize the federal regulatory system governing...more

OSHA Enforcement Memo and Interim Policy on the Process Safety Management Retail Exemption

The Occupational Safety and Health Administration issued yesterday an enforcement memo (Memo) and an interim policy (Policy) on the PSM retail exemption. Tho Memo revised OSHA’s interpretation of the exemption of retail...more

Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...more

Federal Circuit Finds Biosimilar Patent Dispute Resolution Procedures Optional

In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants...more

OSHA Announces Directive on HazCom

The Occupational Safety and Health Administration (OSHA) released its much-anticipated directive to the agency’s compliance safety and health officers on its revised Hazard Communication (HazCom) standard yesterday. In 2012,...more

Wrap-Up of Federal and State Chemical Regulatory Developments, July 2015

EPA Seeks Comment On Series 810 Test Guidelines: On June 17, 2015, the U.S. Environmental Protection Agency (EPA) announced the availability for comment of several Series 810, non-binding, draft test guidelines developed by...more

Website Accessibility: Department of Justice’s Filings in Lawsuits Give Warnings

For many years, the U.S. Department of Justice, an enforcer of the accessibility provisions (Title III) of the Americans with Disabilities Act, applicable to public accommodations, has dragged its feet on promulgating...more

House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more

EPA Gets Closer To Issuing Final Rule On Revisions To Minimum Risk Exemption For Pesticides

On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the...more

EC JRC Publishes Options for the Review of the EC Nanomaterial Definition

The European Commission (EC) Joint Research Center (JRC) announced on July 10, 2015, the publication of its third report in its review of the EC recommendation on the definition of a nanomaterial. The report is the last in a...more

Australia Publishes Final Report on Regulatory Considerations for Nanotechnologies for Pesticides and Veterinary Medicines

The Australian Pesticides and Veterinary Medicines Authority (APVMA) published on July 6, 2015, the final report entitled Nanotechnologies for pesticides and veterinary medicines: regulatory considerations. According to the...more

Privacy and Security Guidance: Cloud Computing in the MUSH Sector

I. Purpose of this Guidance Document and How to Apply - This document is intended to be used by decision makers in the MUSH Sector when considering using cloud services....more

Virtual Currencies are Getting Attention from Industry and Bank Regulators

Virtual currencies such as Bitcoin, once a novel means of exchange, have become so commonplace that in May of this year the New York Stock Exchange created a first-of-its-kind index (the “Index”) representing the U.S. dollar...more

FDA Plan to Exempt Medical Devices

The US Food and Drug Administration (“FDA”) recently released updated recommendations to exempt certain unclassified, Class I, and Class II medical devices from premarket notification requirements. The devices include...more

Proposed Rule to Subject Certain Cybersecurity Items to Greater Export Restrictions

The U.S. Department of Commerce Bureau of Industry and Security (BIS) recently published a proposed rule enhancing controls on certain cybersecurity items under the Export Administration Regulations (EAR). Specifically, the...more

Final Drug Shortage Reporting Rules Will Go Into Effect September 2015

Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological...more

White House Announces Plans To Revise the Coordinated Framework for the Regulation of Biotechnology

The White House, through the Office of Science and Technology Policy (OSTP), announced a major initiative to overhaul the regulation of biotechnology products (OSTP Memo), which are products developed through genetic...more

Submission of Supplemental Evidence in an IPR May Be Submitted After the Due Date - International Business Machines Corp. v....

Addressing the circumstances for submitting supplemental evidence in an inter partes review (IPR), the Patent Trial and Appeal Board (PTAB or Board) allowed the petitioner to submit a responsive declaration after the due date...more

2,217 Results
|
View per page
Page: of 89

Follow Science, Computers & Technology Updates on:

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×