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
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...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
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more
On October 7, 2022, Treasury issued final and temporary regulations on the income averaging rules for the low-income housing tax credit (“LIHTC”) under Section 42 of the U.S. Internal Revenue Code of 1986, as amended (the...more
The United States Department of Interior (“DOI”) released on April 12th guidance (“Guidance”) to the states for application of the first $775 million in initial grant funding for plugging orphaned oil and gas wells. The...more
FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...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
The IRS recently issued final instructions for Forms 1094-B and 1095-B and Forms 1094-C and 1095-C . The 2015 Instructions for Forms 1094-B and 1095-B implement a suggestion we made in a previous post relating to the...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
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
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
On July 9, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Medical Device Reporting for Manufacturers (hereinafter “Draft Guidance”). FDA has not updated its formal...more