Final Guidance

News & Analysis as of

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

Blog: FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015. This guidance is a first for the FDA and comes as a product of...more

OMB and Federal Agencies Publish Final Rule on Grants and Cooperative Agreements

On December 19, 2014, the White House Office of Management and Budget (OMB) and 28 federal agencies published in the Federal Register a consolidated interim final rule to implement OMB’s December 2013 final guidance on...more

EPA Issues Guidance for Developing Data-Derived Extrapolation Factors

The U.S. Environmental Protection Agency (EPA) announced on October 3, 2014, the availability of a final document entitled Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

New FDA Cybersecurity Guidance for Medical Device Manufacturers

Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more

Health Care Providers Responding to Ebola: HHS Issues Guidance Reminding Covered Entities that HIPAA Allows the Sharing of PHI in...

The Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) has issued guidance to remind HIPAA-covered entities of the ways in which they are permitted under HIPAA to share protected health information...more

CRTC Provides Guidance on CASL Software Provisions – But Some Uncertainty Remains

From November 10 to 12, 2014, the CRTC provided its interpretation of the software provisions in Canada’s anti-spam law (CASL) in several presentations to industry. The CRTC also posted a specific FAQ about their...more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

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