News & Analysis as of

Final Guidance

CAS Legal Mailbag Question of the Week – March, 2017

by Shipman & Goodwin LLP on

Dear Legal Mailbag: I am sick and tired of parents who think that middle school education is unimportant. Every spring, I receive a spate of emails from parents notifying me that they will be taking their children out of...more

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

FDA Response to Biosimilar Naming Petitionx Just Issued

by Goodwin on

On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their...more

New Approach for Biologic and Biosimilar Names

by Morgan Lewis on

FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products. This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more

Summary of FDA Guidance on the Nonproprietary Naming of Biological Products

On January 12, 2017, the U.S. Food and Drug Administration (“FDA”) released a final Guidance for Industry, Nonproprietary Naming of Biological Products, as part of the Agency’s ongoing efforts to implement the Biologics Price...more

What You Need To Know About the FDA’s Guidance on Postmarket Cybersecurity

by Reed Smith on

The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year. You can link to a full copy here, and we gave you our detailed take on the draft...more

FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity

by Ropes & Gray LLP on

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices. The guidance outlines nonbinding recommendations on how device manufacturers...more

News from Abroad: Summary Report on the Final Guidance from the English Court of Appeal on Second Medical Use Patents

The final decision of the Court of Appeal in the Lyrica® litigation was handed down on 13 October 2016. This litigation, relating to the painkiller pregabalin marketed by Warner-Lambert for the treatment of pain under the...more

FDA Issues Final Guidance Requiring Meaningless Suffixes for Biosimilar Names

Despite nearly universal opposition from both biosimilar makers and innovator companies, FDA has issued final guidance adopting its controversial August 2015 proposal for naming biologics. Under the guidance adopted by FDA,...more

FDA Issues Final Guidance on Postmarket Cybersecurity

by Morgan Lewis on

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

by Hogan Lovells on

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types....more

Come on People Now ... Everybody Get Together, Try to Love One Another: FDA Issues Final Guidance on Quality Agreements

by Arnall Golden Gregory LLP on

Three and a half years after issuing its draft guidance, on November 22, 2016, the Food and Drug Administration released its final guidance, “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance is...more

MDR Reporting Final Guidance

by Reed Smith on

FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”. As with all such guidance documents, it is nonbinding: “It does not establish any rights for any person and is not binding on...more

UK Payment Systems Regulator Publishes Final Guidance on the European Interchange Fee Regulation

by Shearman & Sterling LLP on

The UK Payment Systems Regulator published the final Guidance on its approach to monitoring compliance with the EU Interchange Fee Regulation. The final Guidance consolidates the previous final Guidance published in March...more

Final EU Guidelines on Transaction Reporting, Order Record Keeping and Clock Synchronization Published

by Shearman & Sterling LLP on

The European Securities and Markets Authority published a Final Report providing its responses to the feedback on the proposed Guidelines on transaction reporting, order record keeping and clock synchronization under the...more

Final EU Guidelines on Information regarding Commodity Derivatives and Spot Markets

by Shearman & Sterling LLP on

The European Securities and Markets Authority published a Final Report and final Guidelines on information expected or required to be disclosed on commodity derivatives markets or related spot markets under the Market Abuse...more

The OCC Publishes Final Guidelines on Recovery Planning

On September 29, 2016, the Office of the Comptroller of the Currency (the “OCC”) published final guidelines establishing enforceable standards for recovery planning. The final guidelines generally apply to banks with average...more

NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises...

by King & Spalding on

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s...more

The White House Final Greenhouse Gas Guidance Directs Federal Agencies to Consider Climate Change and Greenhouse Gas Emissions...

by Shearman & Sterling LLP on

On August 1, 2016, the White House Council on Environmental Quality published its final guidance to federal agencies requiring the consideration of greenhouse gas (GHG) emissions and effects on climate change when evaluating...more

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

by McDermott Will & Emery on

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

ESMA Publishes Guidelines for UCITS V Remuneration Policy

by Morgan Lewis on

The guidelines, which apply from 1 January 2017, seek to clarify the concepts of disclosure, governance, and risk alignment in respect of remuneration; in advance of this date, non-EU investment managers of UCITS should...more

EEOC Issues Retaliation Enforcement Guidance

Last month, the Equal Employment Opportunity Commission (EEOC) issued a final enforcement guidance on retaliation claims under the various federal civil rights laws administered by the agency. The guidance will replace...more

FDA Uses Summer to Issue Numerous Device Guidance Documents

by Morgan Lewis on

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

Final Rules and Guidance Issued on “Blacklisting” Executive Order - Controversial Mandate Requires Disclosure of Labor and...

On August 25, 2016, the Federal Acquisition Regulatory Council issued final rules and the Department of Labor (DOL) published final guidance implementing President Obama’s 2014 “Fair Pay and Safe Workplaces” Executive Order...more

Weekly Update Newsletter - August 2016 #3

by PilieroMazza PLLC on

GOVERNMENT CONTRACTS - Fair Pay and Safe Workplaces - DOD, GSA, and NASA issued a final rule amending the FAR to implement Executive Order 13673, Fair Pay and Safe Workplaces, which is designed to increase efficiency...more

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Cybersecurity

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