New FDA medical device framework to improve women’s health
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
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The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
New solution improves machine efficiency, prevents breakdowns, lowers costs and reduces risks whilst providing anytime, anywhere remote monitoring.
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.
Here we run down four new research collaborations in the cell and gene therapy sector, announced by Bayer, BMS, Pfizer and Moderna.
Population pharmaceutical quality assessment could be used to improve the quality consistency of generic drugs, suggests study.
Could plasma-based engineering provide a greener method to produce antimicrobial materials, such as contact-killing, antifouling and drug-release surfaces?
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
Rapid microbiological methods are being enhanced by artificial intelligence (machine learning in particular). The aim is to speed up analysis; increase accuracy; avoid error and introduce a level of automation. Examples include microscopy, colony counting, and microbial characterisation and matching – each of which is based on improvements in image…
Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.
Killian O’Driscoll, Director of Projects at the National Institute for Bioprocessing Research and Training (NIBRT), highlights the plight of a future skills shortage in the global biopharma industry as state-of-the-art therapy production evolves at a rapid pace.
At first glance pharmaceutical packaging such as a tablet carton or medicine bottle appears to be the simplest of things. However, the humble package serves multiple and varied needs and increasingly includes a surprising range of technology. Reddie & Grose LLP’s Zack Mummery, Dale Carter and Andy Attfield explain more.
This application note presents Raman imaging as a tool for pharmaceutical tablet analysis.
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
Here, industry experts from bioMérieux Industry, Charles River, Shimadzu, TA Instruments, Thermo Fisher Scientific and WITec share their research, guidance and pharmaceutical knowledge.
The Centre for Process Innovation (CPI) reveals the National Physical Laboratory, StreamNative and Wyoming will collaborate on new projects to drive digital medicines manufacturing technology.