Valproate, Topiramate, and emerging neurodevelopmental concerns


Part of our Team here at ToxHub published a commentary on the journal Archives of Clinical Toxicology, titled ‘Valproate, Topiramate, and emerging neurodevelopmental concerns’. We delved into the interesting topic of recent neurodevelopment issues due to valproate and topiramate, which earlier this year led the European Union to strengthen warnings on their use during pregnancy or […]

New Approach Methodologies (NAMs)

New Approach Methodologies

In recent years, there has been interest in developing new, faster and less expensive approaches to collect toxicological information. These methods, which researchers aspire to develop for use in place of traditional animal testing, are referred to as new approach methodologies (NAMs). NAMs are defined as any technology, methodology, approach, or combination that can provide […]

MoCRA (Modernization of Cosmetics Regulatory Act)


What is MoCRA? MoCRA stands for Modernization of Cosmetic Regulation Act, and represents the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This is a substantial change, as it introduces obligations for manufacturers and strengthens the FDA’s power to intervene. […]

Borderline Products: Medical Devices or Medicinal Products?

Borderline Products

In the pharmaceutical industry, the correct classification of medical devices and medicines is of pivotal importance, not only for the end-user, but also for regulatory purposes. The problem is that, sometimes, this classification is not so straightforward. Welcome to the case of Borderline products! Borderline products are those products which by their nature are not […]

Nanomaterials: a brief review and regulatory considerations


Nanomaterials are defined as a natural, incidental or manufactured materials consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions[1],[2]: one or more […]

Companion Diagnostics: A Vital Component in Medical Device Advancements

Companion Diagnostics

In the rapidly evolving landscape of healthcare, precision medicine has emerged as a groundbreaking approach to tailor medical treatment to the individual characteristics of each patient. At the forefront of this revolution are companion diagnostics (CDx), an integral component of medical devices that holds the key to unlocking personalized and targeted therapies. Let’s explore the […]

Free From Claims: the assessor’s position

Free From Claims

In the realm of cosmetics, it is imperative that product labels encompass a comprehensive array of mandatory information, ensuring transparency and consumer awareness. Serving as a crucial link of communication, these labels elucidate essential details about the cosmetic product to the end user. Beyond mere formality, adhering to these label requirements reflects a commitment to […]

D4, D5 and D6: Substances of Very High Concern

D4, D5, D6

Back on November 9, 2023 the European Court of Justice, after a long legal battle against Global Silicones and others (the list is long: Dow Silicones UK Ltd, Evonik Operations GmbH, Shin-Etsu Silicones Europe BV, just to name a few) confirmed the classification of D4, D5 and D6 as substances of very high concern (SVHC), […]