EU MDR and IVDR implementation and deadlines – Proposal for EU MDR application delay

The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on 25 May 2017 replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD). As indicated in the regulations, from the date the regulations entered into force, …

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GDPR: What is it and what does it mean for your clinical studies: Part II

This two-part blog serves to summarize Covance 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 Covance Medical Device and Diagnostic Solutions through a review of the …

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GDPR: What is it and what does it mean for your clinical studies: Part I

This two-part blog serves to summarize Covance 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 Covance Medical Device and Diagnostic Solutions through a review of the …

Managing global release in a changing regulatory environment

An analytical testing perspective Whether you are using an insourcing or outsourcing strategy and working with a CMO or CRO, biotechs and pharmaceutical companies are all pointing toward the same goal: rapidly achieving commercialization of their therapy. However, there are multiple approaches in early phase development that can greatly affect …

Biomarkers & Diagnostics: Growing Influence on Drug Development for NAFLD/NASH

Biomarkers and diagnostics are playing an ever-increasing role in drug development. Personalized medicines, defined as drug therapies used alongside specific diagnostic tests, topped 40% of all FDA approvals in 2018. Across biopharma, drug developers increased their utilization of selection biomarkers, significantly improving the probability of success for their clinical programs.1, …

Covance Becomes First Major Central Laboratory in Japan to Add Anatomic Pathology and Histology Services

In an effort to help clients get faster clinical trial results and support development of today’s novel therapies, Covance recently expanded its Asia-Pacific footprint by becoming the first major central laboratory in Japan to add anatomic pathology and histology (APH) services at its Kawagoe facility. Learn more about how this …

Speeding Hand Disinfectant Products into the EU Market in Response to the Demand Driven by Covid-19

An unprecedented challenge The coronavirus (Covid-19) pandemic has increased the demand for hand disinfectants, driven by recommendations from bodies such as the WHO. Hand washing is a vital measure for reducing the risk of contracting the virus. The WHO specifically recommends that all individuals “Regularly and thoroughly clean your hands …