Standards & Regulations

Feb 01, 2014
BioPharm International
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
Feb 01, 2014
BioPharm International
High technology assessments are having an impact on biosimilars development in Europe.
Jan 30, 2014
By BioPharm International Editors
EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.
Jan 24, 2014
By BioPharm International Editors
FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location
Jan 09, 2014
By BioPharm International Editors
FDA releases guidance on the qualification of drug development tools.
Jan 09, 2014
By BioPharm International Editors
FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.
Jan 01, 2014
BioPharm International
Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.
Dec 31, 2013
By BioPharm International Editors
Genzyme plans to appeal FDA?s decision that the multiple-sclerosis treatment is not ready for approval.
Dec 31, 2013
By BioPharm International Editors
Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US.
Dec 30, 2013
By BioPharm International Editors
Baxter International recalls dextrose injection and four sodium chloride injections.
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