Final Guidance

News & Analysis as of

Immigration Update: Precedent Decision Impacts H-1B Workers & Employers

USCIS has issued a final guidance memorandum in regards to the precedent AAO decision in the Matter of Simeio Solutions, LLC. Per the Simeio decision, an amended H-1B petition must filed with USCIS when there is a material...more

USCIS Releases Final Guidance on H-1B Job Site Changes

U.S. Citizenship and Immigration Services (USCIS) released final guidance on a recent Administrative Appeals Office (AAO) decision requiring amended or new H-1B petitions for workers who change job sites. These requirements...more

USCIS Releases Final Guidance on H-1B Job Site Changes

On Tuesday July 21, 2015, U.S. Citizenship and Immigration Services (USCIS) released final guidance on a recent Administrative Appeals Office (AAO) decision requiring amended or new H-1B petitions for workers who change job...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

Client Alert for H-1B Employers – Importance: High

Amended H-1B Petitions May be Required Immediately - Applies to: All employers with H-1B employees working at job sites other than those specified in H-1B filing. Action needed now: Verify that actual work site of...more

FCA’s Concurrent Competition Powers – Final Guidance and Handbook Amendments Are Published

The FCA has published final guidance on use of its new competition law powers, together with amendments to its Handbook introducing a specific competition law self-reporting obligation which will have significant...more

ALERT: NIST Issues Final Guidance on Federal Contractor Cybersecurity Standards for Controlled Unclassified Information

On June 19, 2015, the National Institute of Standards and Technology (NIST) published the final version of guidance for federal agencies to ensure sensitive information remains confidential when stored outside of federal...more

EBA Issues Guidelines on Management of Interest Rate Risk Arising from Non-Trading Activities

On May 22, 2015, the European Banking Authority (EBA) published its final guidelines on the management of interest rate risk arising from non-trading activities (EBA/GL/2015/08). The guidelines cover the management of...more

EBA Issues Guidance on the Implementation of Resolution Tools

The EBA has published three sets of final guidelines aimed at facilitating the implementation of resolution tools in the banking sector across the EU. The guidelines have been developed under Articles 39, 42 and 65 of the EU...more

ESMA Releases Final Guidance on the Definition of Physically Settled Commodity Derivatives Under MiFID I

On May 7, the European Securities and Markets Authority (ESMA) issued final guidelines (Guidelines) clarifying the definition of physically settled commodity derivatives under the Markets in Financial Instruments Directive...more

FDA Finalizes Guidance Documents on Biosimilars

Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance...more

FDA Issues Three Biosimilar Final Guidances

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are...more

FDA Initiates Expedited Access Pathway Program for Medical Devices via Final Guidance Document

The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more

FDA Releases "Final" Guidances for Industry regarding the Biosimilar Approval Pathway

About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of...more

Canadian Securities Administrators Adopt National Policy 25-201 Guidance for Proxy Advisory Firms

On April 30, 2015, the Canadian Securities Administrators (CSA) adopted National Policy 25-201 Guidance for Proxy Advisory Firms. The Policy may be viewed on the websites of CSA members, including the Alberta Securities...more

FDA Finalizes Guidance Documents on Biosimilarity

On Tuesday, and over three years after the initial guidance documents were released, the US Food and Drug Administration released final versions of three guidance documents discussing how FDA will evaluate applications for...more

FCA Finalizes Guidance on Multilateral Trading Facilities

On April 15, the Financial Conduct Authority (FCA) published its final guidance (Final Guidance) relating to the operation of multilateral trading facilities (MTFs) pursuant to the FCA’s applicable market conduct rules (MAR...more

UK Regulator Announces Its Approach to Financial Promotions in Social Media

On March 13, the UK regulator, the Financial Conduct Authority (FCA) published finalized guidance on its supervisory approach to financial promotions in social media (the “Guidance”). The range of social media within the...more

Alert: Financial Promotions in Social Media for the UK

The FCA published its Finalised Guidance (FG15/4) on Social media and customer communications: The FCA's supervisory approach to financial promotions in social media on 13 March 2015 (Finalised Guidance). ...more

NLRB General Counsel’s report on employee handbook rules provides some guidance . . . but employers may not like it

As we have previously reported, the National Labor Relations Board in recent years has put employee handbooks and policy manuals under a magnifying glass, searching for any provision that might, in its view, violate the...more

FDA Issues Final Guidance on Reprocessing of Medical Devices

The US Food and Drug Administration (FDA) issued a final guidance document on March 12 titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” Although the final guidance was expected...more

IIROC Releases Final Guidance for Underwriting Due Diligence in Public Offerings

On December 18, 2014, the Investment Industry Regulatory Organization of Canada (IIROC) published, with immediate effect, Rules Notices 14-0299 and 14-0300 in connection with the release of final guidance (Final Guidance)...more

China Announces Final Biosimilars Guideline

The Center for Drug Evaluation (the “CDE”) under the China Food and Drug Administration published final biosimilars guidance on February 28 with immediate effect. Officially titled the Technical Guideline for the Research,...more

FDA Will Not Enforce Regulatory Controls for Medical Device Data Systems and Two Other Health IT Devices

In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration (FDA) posted final guidance announcing its intent to exercise enforcement...more

REMIT: the countdown to full implementation begins as final data reporting rules are published

The REMIT Implementing Acts on data reporting obligations entered into force on 7 January 2015. This document is the final guidance setting out the rules for reporting wholesale energy products and fundamental data in the EU...more

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