The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health. / read more /
The new course is directed at analysing the skills gap in the manufacture of cell and gene therapies as they progress toward manufacturing at scale. / read more /
The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity. / read more /
As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced. / read more /
The new company will work to provide the manufacturing technologies and processes needed to develop and commercialize new cell and gene therapies through individual company products and expertise. / read more /
The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017. / read more /
The UK’s MHRA has been recognized for its support of the development of an on-demand educational platform leveraging the power of virtual reality (VR), Virtuosi, from Quality Executive Partners (QxP). / read more /
The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies. / read more /
Regulatory mandates, niche diseases, and patient-centric solutions have all impacted pharma packaging over the years and are expected to help shape the future of the sector. / read more /
Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market. / read more /
In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions. / read more /
Safe Packaging for Healthy Products Pharma bottles are an integrated part of the final medicine. That’s why Stoelzle cares that much about quality and reliability when manufacturing safe packaging for healthy products in soda lime Type III quality. / read more /
Cleanroom Documentation Systems VAI has solved the challenges surrounding particulate and fiber contamination in controlled areas by developing CleanPrint 10, the Core2Print, and Core2Write and has addressed cleanroom traceability via our Core2Scan System. / read more /
Pharmaceutical Technology’s Regulatory Sourcebook and Reference highlights regulatory trends and enforcement actions, risk-based studies for analytical procedure validation, and generic drug applications, as well as a detailed analysis of pharmacopoeia requirements, challenges with compliance.
