Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
Compliance Tip of the Day: Avoiding CCO Liability
Compliance Tip of the Day: COSO Governance Framework - Part 5, People
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Balch’s Consumer Finance Compass: How Standing Can Make or Break Certification for Class Action Lawsuits in Debt Collection
Top challenges with Compliance Management
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
Daily Compliance News: July 15, 2025, The Fighting Workplace Bullying Edition
Compliance Tip of the Day: Design - Centric Internal Controls
Treating Compliance Like an Asset
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
#Risk New York Speaker Series – Exploring Future Regulatory Trends and Compliance Strategies with Rory McGrath
The Capital Ratio Podcast | Entering the US Banking Market
SCOTUS Clean Air Act Cases: What’s New?
First 100 Days of the New HSR Rules with Antitrust Partner Kara Kuritz
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
From Permits to Penalties: A Deep Dive Into Coastal Development Law
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions
The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide (Victoza®), semaglutide (Ozempic®, Wegovy®), and tirzepatide (Mounjaro®, Zepbound®). Although...more
On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...more
Four U.S. senators reported their findings of a nine-month investigation into direct-to-consumer telehealth platforms used by pharmaceutical manufacturers, highlighting risks and reinforcing the need for industry to carefully...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in Advisory Opinion (AO)...more
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
Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more
Federal Controlled Substance Act regulations require that prescriptions for controlled substances be issued only for legitimate medical purposes by individual practitioners acting in their usual course of professional...more
In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more
On June 19, 2025, Canada’s Drug Agency (“CDA”) opened a public consultation to gather input on a proposed list of essential prescription drugs and related products. This initiative is part of the agency’s responsibilities...more
The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more
Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more
Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories....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
The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. ...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
On June 19, 2025, Canada’s Drug Agency (CDA) opened a public consultation on a proposed process for preparing a list of essential prescription drugs and related products. As required by the Pharmacare Act, the CDA must...more
Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more
State laws seeking to regulate pharmacy benefit managers (PBMs) have increased significantly over the past few years. As it stands, all 50 states have laws that regulate PBMs in some way, but all are unique. However, most of...more
In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more