USP and British counterpart join forces
Pharmacopoeias in the US and in the UK have signed a memorandum of understanding to strengthen quality standards for medicines
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FDA partners with university on biopharmaceutical manufacturing
Delaware University and the FDA will have the ability to collaborate in a pre-competitive environment
University in Virginia starts first US pharma engineering PhD
Qualification will train students in manufacturing procedures focusing on areas of drug product development such as ...
CARBOGEN AMCIS announces successful FDA inspection
The Hunzenschwil facility is one of the company's four sites to offer development and manufacturing facilities for ...
The power of real-world patient data
Real-world data has the potential to vastly improve the effectiveness and efficiency of the drug development pipeline, ...
CPhI MEA expert comments on booming business in the Middle East
Opportunities abound at CPhI MEA and experts anticipate regional generic companies acting as CMOs for international ...
FDA approves nine companies for first generics of Lyrica
The nine companies are based mostly in the US and India with one located in Israel
The future of supply chain management in pharmaceuticals
Global regulations and local legislation have made serialisation in the pharmaceutical industry standard practice. And, ...
Almac Pharma Services announces September workshop series
Experts will guide participants through the product launch timeline from Phase 3 to commercial launch
EMA publishes draft guideline on quality requirements for DDCs
The latest document focuses on combinations of medicinal products and medical devices
Saleable returns verification: What you need to know about enforcement discretion
We are aware of the speculation that the US FDA may announce a delay in enforcement action for the DSCSA’s November ...
Review: Cannabis Europa 2019
Scientists, businesspeople and politicians backing the regulation of medical and recreational cannabis have taken the ...
US Patent and Trademark office declares new CRISPR interference
The new motion follows on from a long history of confusion over the intellectual property of CRISPR/Cas9 technology in ...
WuXi STA Shanghai and Changzhou facilities pass US FDA inspections
Chinese CDMO has passed seven inspections from the US FDA since 2013
Legacy ramps up preparations for Russian track-and-trace regulations
Swiss pharma supplier has installed and certified new Bosch serialisation and aggregation equipment on three packaging ...
In Brief
Most Popular in Regulatory
- FDA partners with university on biopharmaceutical manufacturing
- University in Virginia starts first US pharma engineering PhD
- Saleable returns verification: What you need to know about enforcement discretion
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