The European Chemicals Agency (ECHA) recently conducted a review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study, or EOGRTS). The project’s goal was to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently …
How to answer basic physical chemical questions for your chemical and agrochemical substances when test guidance changes and as regulatory standards evolve
Although most physiochemical endpoints are standard for crop and chemical active substances, selection of the right test method to assess them is critical. This blog reviews some standard endpoints and looks at the tests used, in the light of changing regulatory expectations and revised test methodologies for difficult substances.
GDPR: What is it and what does it mean for your clinical studies: Part I
This two-part blog serves to summarize the Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by our Medical Device and Diagnostic Solutions through a review of the …
The simple steps to successful active substance renewal in the EU
In the EU, the renewal procedure for existing plant protection active substances (under the “AIR” program) requires advance planning and careful management to comply with ever-evolving regulatory requirements. Read below for practical advice on how to prepare your renewal applications and discover how Labcorp can support you. 1. Form a …
Are your CERs ready for MDR?
Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex. The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. Now, even with the all but official postponement of …
Using data visualization tools on SEND datasets: a graph is worth a thousand data points
SEND [Standard for Exchange of Nonclinical Data] is more than just a tool to facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and …
Designing a comprehensive drug discrimination study
Series Introduction: View all articles in this series. Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Abuse Potential, we are sharing how we design and …
The Biosimilars Landscape: What All Developers Need to Know
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, …