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
As we’ve discussed previously (see here and here), the National Labor Relations Board (“NLRB”) has recently endeavored to work collaboratively with other federal agencies to combat workplace issues where multiple agencies may...more
On 14 May 2024, the European Securities and Markets Authority (ESMA) published its final guidelines ESMA34-472-440 Final Report on the Guidelines on funds names (europa.eu) on the use of ESG- or sustainability-related terms...more
The United States Equal Employment Opportunity (“EEOC”) has issued its final guidance on “Enforcement Guidance on Harassment in the Workplace,” the first of its kind in over 20 years. This final guidance builds on a variety...more
Guidelines indicate when asset managers may legitimately use ESG or sustainability-related terms in their fund names. On 14 May 2024, ESMA published its final Guidelines on funds’ names using ESG- or...more
The Treasury Department and IRS recently issued final regulations on the transfer of certain credits to implement the transferability provisions of the Inflation Reduction Act (IRA), which take effect on July 1, 2024....more
The Federal Register on May 6, 2024, published final regulations issued by the U.S. Department of the Treasury and IRS under the clean vehicle tax credits found at Sections 25E (previously owned clean vehicles) and 30D (clean...more
It is no secret that the Federal Reserve, the FDIC, and the OCC have zeroed in on banks' use of third parties for products, services, and other operations, the risks those arrangements may pose, and banks' responsibility to...more
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more
On April 29, 2024, the U.S. Equal Employment Opportunity Commission (EEOC) issued final guidance on workplace harassment subject to federal employment discrimination laws. Aptly titled, “Enforcement Guidance on Harassment in...more
On April 29, 2024, the Equal Opportunity Commission (“EEOC”) released its final guidance Enforcement Guidance on Harassment in the Workplace (the “Final Guidance”)....more
On April 15, the Equal Employment Opportunity Commission (EEOC) issued its long-awaited final rule and interpretive guidance implementing the Pregnant Workers Fairness Act (PWFA). As noted in AFS’s previous alerts (here...more
On April 22, 2024, the Office of Management and Budget (“OMB”) issued final guidance regarding the application of the Section 889 telecommunications ban to federal grants, loans, and cooperative agreements under 2 C.F.R. §...more
On March 5, 2024, the US Food & Drug Administration (FDA) released final guidance titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance is meant to...more
On December 19, 2023, the Department of Energy (“DOE”) Grid Deployment Office released final guidance on how it will designate National Interest Electric Transmission Corridors (“NIETC”) pursuant to Section 216(a) of the...more
In February 2024, the U.S. Food and Drug Administration (FDA) published its finalized guidance concerning its investigational drug charging regulations (found at 21 C.F.R. § 312.8). These regulations are applicable to...more
On March 5, FDA published its long-awaited Final Guidance on New Dietary Ingredient Notification (NDIN) Procedures and Timeframes (Final Guidance). This new guidance updates and finalizes Section V of FDA’s revised 2016 Draft...more
On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more
On March 5, 2024, the U.S. Department of Treasury and Internal Revenue Services (IRS) released final regulations regarding the direct payment election under the Inflation Reduction Act of 2022 (IRA), a tax credit monetization...more
On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more
In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...more
Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of...more
The Situation: In October 2023, the Office of the Comptroller of the Currency ("OCC"), Federal Reserve System, and Federal Deposit Insurance Corporation ("FDIC," and the three agencies collectively, "Agencies") finalized...more
Last week, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, a new electronic submission portal for the registration and listing of cosmetic product facilities and products under the Modernization of...more
The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) is part of the Food and Drug Omnibus Reform Act of 2022 (FDORA) that President Biden signed into law late last year. MoCRA greatly expands the FDA’s oversight...more
The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties. On August 31, 2023, the US Food and Drug Administration (FDA or...more