How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies

Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario.

ISO 14155 update: key risk management changes for medical device clinical investigations in 2019

The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.

Treating age-related macular degeneration (AMD) with a novel stem cell therapy

The Audacious Goals Initiative (AGI) for regenerative medicine is a program run by the National Eye Institute (NEI), aimed at finding new therapies for eye diseases that remain difficult to treat.

What’s changing in SEND 3.1?

The SEND [Standard for Exchange of Nonclinical Data] Implementation Guide v3.1, “SEND 3.1,” changes the model for the reporting of cardiovascular and respiratory endpoints.

Future-proofing residue analysis services

As the regulatory landscape across the globe is rapidly evolving, more sophisticated requirements must be met by registrants and scientists. In parallel, scientific advances have impacted previous methodologies that were once seen as cutting edge but now may fail to adequately address new regulatory challenges.

Preserving lifecycles: renewing established pesticides

The regulation that governs the marketing, sale, and use of pesticides is just a fact of life, but the standards imposed are constantly evolving as our scientific insight and knowledge increases. This series of informational blogs is designed to examine how existing active substances (ASs) are managed through the current regulatory renewal systems in the EU and USA.

Understanding Annexes VII-X

In the EU, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations address the manufacturing and import of chemicals to ensure they are safe for human health and the environment. The registration dossier outlines the standard information requirements for a substance and minimum data required that describe the physicochemical, toxicological, environmental fate and ecotoxicological properties of the substance.

5 different kinds of cytokine release assays: weathering the storm | CRA Post II

In our previous post, we outlined the dangers of Cytokine Release Syndrome (CRS) and the importance of preclinical Cytokine Release Assays (CRAs) when developing monoclonal antibodies (mAbs) that interact with the patient’s immune system. In this second post, we describe the different kinds of assays in use and how these may fit into your drug development program. An alternative type of CRA, peripheral blood mononuclear cell (PBMC) blood outgrowth endothelial cell (BOEC) co-culture, will be discussed in more detail in our next blog post.

In vitro cytokine release assays: is there calm after the storm? | CRA Post I

Cytokine Release Syndrome (CRS), otherwise known as cytokine storm, is a systemic inflammatory response caused by complications due to disease, infection or an adverse effect of biologic therapy. The clinical symptoms of a cytokine storm are massive release of a potent cocktail of pro-inflammatory cytokines into the general circulatory system, leading to severe multi-organ damage, failure or potentially death. This is an extremely unwanted immunotoxicological side effect in drug development.

RA biosimilar studies recruitment strategy? How to succeed despite increasing volume of RA biosimilar development programs

Although a range of regulatory definitions exist, a biosimilar drug is generally defined as a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1