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AI Today in 5: August 22, 2025, The Angst Episode
Point-of-Sale Finance Series: Understanding the Development and Regulation of Buy Now, Pay Later Products — The Consumer Finance Podcast
Daily Compliance News: August 21, 2025, The Fabricated Evidence Edition
Understanding BBB Ratings: Strategic Approaches to Consumer Complaints — Regulatory Oversight Podcast
The Road to Regulation: Vehicle Service Contracts Explained — Moving the Metal: The Auto Finance Podcast
Hospice Insights Podcast - Hospice Audit Updates: Hospices Fare Well in Federal Court
Podcast - An Overview of State Attorney General Consumer Protection Enforcement
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AI Today in 5: August 5, 2025, The AI at the SEC Episode
Episode 381 -- NAVEX's 2025 Annual Hotline Report
Podcast - Regulating AI in Healthcare: The Road Ahead
Daily Compliance News: August 1, 2025, The All AI Edition
Wild Times for the Community Reinvestment Act
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Understanding BBB Ratings: Building Trust and Mitigating Risks — Regulatory Oversight Podcast
Daily Compliance News: July 23, 2025 the Pardon in the Wind? Edition
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The Capital Ratio Podcast | Entering the US Banking Market
Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more
On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more
On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more
The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update on the timing of the reform of the current UK legislation, the Medical Device Regulations 2002 (UK MDR), and the transitional arrangements...more
The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more
On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. ...more
This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more
The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or...more
The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more
The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric...more
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more
In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications. In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more