Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Wiley Webinar: Biotech Briefings – Interim Update on Regulatory Developments Relevant to Plant Biostimulants
Edible Bites Episode 2: Cannabis and Life Sciences Video Webinar Series
In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
On February 12, the SEC’s Division of Corporation Finance issued Staff Legal Bulletin No. 14M (SLB 14M) to update its guidance on the “economic relevance” and “ordinary business” exclusions in Exchange Act Rule 14a-8, which...more
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
1. Bank regulation - 1.1 PRUDENTIAL REGULATION - a) General - (i) International - FSB: Plenary December 2024 - Status: Final - The FSB has set out the outcomes of its Plenary that met on 3 and 4 December. Points of...more
FCA publishes final guidance on regular premium PPI complaints and new consultation on mailing rules....more
On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more
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
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
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
This week marks the three-month anniversary of the effective date of Regulation A. Of course, given this limited experience, it may be premature to comment on market developments. Instead, below we summarize significant...more
On June 30, 2014, the SEC issued long-awaited guidance on an investment adviser’s use of third-party proxy advisory firms such as ISS and Glass Lewis. Due to a number of regulatory developments over the past ten years,...more
The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors...more