Cosmetic Packaging Safety: Key Considerations and Insights

Cosmetics

Cosmetic products constitute an extremely broad and heterogeneous category of consumer goods that, in accordance with current regulations, must ensure their safety. This applies to both the product itself and its packaging, ensuring that the latter does not alter the safety characteristics of the cosmetic. In the cosmetic sector and various consumer goods sectors, packaging […]

Investigator’s Brochures for Medical Devices: key elements

Investigator's Brochures

Right in April 2024, the European Commission’s Medical Device Coordination Group (#MDCG) published their latest guidance, illustrating all things concerning the Investigator’s Brochure (IB) needed for clinical investigations of medical devices. What is an Investigator Brochure? The IB is a comprehensive document compiled by the sponsor of a clinical trial that provides detailed information about […]

Toxicological Risk Assessment – TRA

Toxicological Risk Assessment TRA

One topic in which we are experts here at ToxHub are Toxicological Risk Assessment (TRA) for medical devices, conducted according to ISO 10993-17! For short, a TRA it’s an assessment of product safety, conducted taking into account its composition and intended purposes. This evaluation can be done only by board-certified toxicologists, like our Carla Landolfi, […]

Valproate, Topiramate, and emerging neurodevelopmental concerns

Valproate

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)

MoCRA

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

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 […]