The Brexit1 transition period is due to conclude on December 31, 2020 when the United Kingdom (UK) will become a third country to the European Union (EU). Drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing and Brexit. …
What the new EU endocrine disruptor assessment means for renewal of your active ingredients
Introduction The new EU requirements for endocrine disruptor identification will impact any active ingredient (AI) renewals with expected decisions from November 2018 onwards. Learn more about these requirements and key strategies to meet them, below[CS1] [CS2]. The European Commission has adopted new criteria for identifying endocrine disruptors (EDs) – these criteria …
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 …
In vitro cytokine release assays: is there calm after the storm? | CRA Post I
What is a cytokine storm? 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 …
What you need to know about neonicotinoids and the EU
Introduction Neonicotinoids were developed to find safer, more effective alternatives to chlorinated hydrocarbons, organophosphates, carbamates, and pyrethroids, so, ironically, some neonicotinoids are now banned in the EU because of their toxicity to bees and other pollinators, as well as to a wider group of species. The agricultural and environmental consequences …
RA biosimilar studies recruitment strategy? How to succeed despite increasing volume of RA biosimilar development programs
Introduction 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 …
Understanding Annexes VII-X
Avoiding obstacles with REACH Annexes VII-X Posted by Dr. David Howes, Informed Consultant in Chemical Legislation and Chemistry. 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 …
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 …
Listening to – and learning from – the voice of the patient
Patient recruitment represents the biggest challenge in clinical trials. From general patient identification and participation to reducing screen failure rate or limiting patient drop out after enrollment, drug developers face many massive pain points to initiate their clinical trials. Patient recruitment and retention continue to be the biggest challenge in …
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. Clients should consider techniques to …