Quality Systems

Apr 19, 2018
By BioPharm International Editors
The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
Apr 19, 2018
By BioPharm International Editors
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
Apr 16, 2018
By BioPharm International Editors
A new report gives an overview of the work of the International API Inspection Program.
Apr 13, 2018
By BioPharm International Editors
Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.
Apr 11, 2018
By BioPharm International Editors
The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.
Apr 11, 2018
By BioPharm International Editors
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
Apr 09, 2018
By BioPharm International Editors
Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
Apr 06, 2018
By BioPharm International Editors
The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.
Apr 05, 2018
By BioPharm International Editors
The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.
Apr 03, 2018
By BioPharm International Editors
The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.
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