News & Analysis as of

Final Guidance

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

by Hogan Lovells on

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more

Final Guidance on IRB Written Procedures Issued

by Morgan Lewis on

The guidance is intended to assist institutional review boards and institutions in developing written procedures. Whether an IRB has written procedures on the topics identified in the guidance may also be a useful benchmark...more

Final EU Guidelines on Internalized Settlement Reporting Under the Central Securities Depositories Regulation

by Shearman & Sterling LLP on

The European Securities and Markets Authority has published final Guidelines on Internalized Settlement Reporting under the Central Securities Depositories Regulation. The CSDR, which introduces common standards for...more

Next Steps in the Asset Management Market Study

by Latham & Watkins LLP on

FCA publishes final rules and further consultation on outstanding remedies under its asset management market study. Key Points: ..The FCA has published a Policy Statement (PS18/8) setting out final rules and guidance...more

European Securities and Markets Authority and European Banking Authority Final Guidelines on Suitability of Management Body...

by Shearman & Sterling LLP on

Following consultation in late 2017, the European Securities and Markets Authority and European Banking Authority have jointly published final Guidelines on the assessment of the suitability of members of management bodies...more

EPA Releases Final Guidance on Placement of First Aid Statements on Pesticide Labels

by Bergeson & Campbell, P.C. on

On March 8, 2018, the U.S. Environmental Protection Agency (EPA) announced its release of final guidance clarifying where first aid statements should appear on the label of pesticide products. EPA also posted a response to...more

FDA Provides Guidance on How to Formally Request Informal Feedback on Product Designation from the Office of Combination Products

by Arnall Golden Gregory LLP on

Earlier this month, the Office of Combination Products of the Food and Drug Administration issued a final guidance for industry, How to Prepare a Pre-Request for Designation (Pre-RFD). The final guidance does not vary...more

UK Joint Money Laundering Steering Group Publishes Final Revised Guidance for Financial Services

by Shearman & Sterling LLP on

The Joint Money Laundering Steering Group has published final revised guidance on anti-money laundering and counterterrorist financing for the financial services sector...more

Examiners are Carefully Scrutinizing Financial Institutions’ Compensation Arrangements

by Ruder Ware on

It has come to our attention that some examiners have recently been carefully scrutinizing financial institutions’ employee compensation arrangements. Although it now appears unlikely that the proposed Dodd-Frank rules on...more

FDA Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist

by Hogan Lovells on

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo Classification Process (Evaluation of Automatic Class III Designation) (Final...more

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

by Arnall Golden Gregory LLP on

On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more

Final EU Guidelines on Information Required for Authorization Applications by Payment Institutions

by Shearman & Sterling LLP on

The European Banking Authority has published final Guidelines on the information to be provided for the authorization of payment institutions and electronic money institutions, and for the registration of account information...more

FDA Issues Final Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more

FDA Issues Long-Awaited Final Guidance on When a Device Modification Requires a New 510(k)

by Hogan Lovells on

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the...more

Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

by Hogan Lovells on

On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

Working Together: FDA Releases Final Guidance on Interoperability

by Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

FDA Issues Final Drug and Device Classification Guidance

by McDermott Will & Emery on

This week, the FDA published final guidance outlining the agency’s current thinking with respect to the classification of products as drugs or devices, respectively. The final guidance summarizes the agency’s position with...more

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

by Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

Leveraged Lending: Summary of ECB Guidance compared to US Guidance

by Shearman & Sterling LLP on

In May 2017, the European Central Bank published its final Guidance on Leveraged Transactions (the “ECB Guidance”). The ECB Guidance will come into effect six months after publication and will apply to all “significant credit...more

ECB Guidance on Leveraged Transactions

by White & Case LLP on

The European Central Bank ('ECB') published its final guidance ('Final Guidance') on leveraged transactions on 16 May 2017, marking the end of a public consultation process that began on 23 November 2016. In addition to its...more

European Central Bank Publishes Final Guidance on Leveraged Transactions

by Latham & Watkins LLP on

The ECB final guidance reflects market feedback and is more closely aligned to the US leveraged lending guidance. The European Central Bank (ECB) published the long-awaited final guidance on leveraged lending on 16 May...more

Cybersecurity Disclosures: A How-To Guide

In October of 2011, the U.S. Securities and Exchange Commission (“SEC”) issued guidance regarding a public company’s obligations to disclose cybersecurity risks and cyber incidents (the “Cybersecurity Disclosure Guidance”)....more

UK Prudential Regulation Authority Publishes Final Consolidated Guidance on Remuneration

by Shearman & Sterling LLP on

The Prudential Regulation Authority has published a Policy Statement and final consolidated Supervisory Statement on its expectations on remuneration. In the latter part of 2016, the PRA consulted on its proposed changes to...more

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

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