10 For 10: Top Compliance Stories For the Week Ending August 16, 2025
Moving Beyond the Usual Helpline Data
Episode 381 -- NAVEX's 2025 Annual Hotline Report
Podcast - Regulating AI in Healthcare: The Road Ahead
Great Woman in Compliance: The Power of Vulnerability with Cricket Snyder
Everything Compliance: Shout Outs and Rants: Episode 157, No To Ukraine Corruption
Avoiding a Bored Board
Podcast - Tips for Maintaining FTC Compliance When Using AI
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
FCPA Compliance Report: Ethical Challenges in AI, Data Protection, and Sports with Andre Paris
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
Great Women in Compliance – Compliance is the Floor, Ethics is the Ceiling with Ellen Hunt
Great Women in Compliance: Creating Space to Speak Up: The Story Behind Psst.org
Regulatory Ramblings: Episode 64 – Building Inclusion Through Sustainable Leadership / The EU Omnibus Proposal with Janet Ledger and Dr. Inna Amesheva
Hidden Fees in the Live-Event Ticketing and Short-Term Lodging Industries
Digital Planning Podcast Episode: Estate Planning and the Corporate Transparency Act
Episode 330 – Halyna Senyk on Anti-Corruption Progress in Ukraine
ESG Masterclass — ESG and Impact Investing
FCPA Compliance Report – Jonathan Wilson on The NSBU Decision
Áine Bryn of Mercer UK on Demonstrating the Strategic Credibility of the Marketing Function - Passle's CMO Series Podcast
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more
Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more
As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the...more
Food/Dietary Supplements - FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. ...more
Food/Dietary Supplements - FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. ...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
Prescription drug pricing in the U.S. has received significant and widespread attention lately from the media, consumers, and the government. For example, the Washington Post ran an article that examines the sometimes opaque...more
On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used “certain ‘gaming’ tactics to delay generic competition.” The list is intended to...more
Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA...more
The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more
On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs”...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more