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Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
Due to the demand caused by the COVID-19 pandemic, the UK government has said British manufacturers will produce the majority of PPE by the end of the year.
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
This article explores the reasons behind the introduction of the EU Medical Device (MDR) and In Vitro Diagnostic Devices (IVDR) regulations, the problems that beset them and how COVID-19 finally persuaded the European Commission that a further year’s preparation time for full application of the regulations was necessary.
Researchers reveal that for early breast cancer a single dose of targeted intraoperative radiotherapy (TARGIT-IORT) is as effective at preventing breast cancer recurrence as the standard of care.
Dr Stephane Gobron explores three different ways that manufacturers can use to bring their PPE up to regulatory standard.
This article explores what pharmaceutical companies could be doing to promote injectable biosimilar approval and consumer uptake.
The cervical dysplasia drug-device product, APL-1702 (Cevira®), offers an alternative to surgery and has been approved to start a clinical trial in China and several other countries.
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
The sustainable device, consisting of food industry by-products, had excellent biocompatibility both in vitro and in vivo.
The founder of Apple Steve Jobs once said, “Great things in business are never done by one person; they’re done by a team of people.” This is true now more than ever as medical device manufacturers and companies from a range of industries work together in the fight against COVID-19.…
Abbott has revealed its SARS-CoV-2 antibody test was not designed for at home use despite companies selling them for this purpose. Also, what do experts think about these tests?
Following the recall of Spartan Bioscience's COVID-19 test by Health Canada, a report suggests this demonstrates the challenges associated with rapid approval.
