Standards/Regulations

Apr 20, 2018
By BioPharm International Editors
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
Apr 20, 2018
By BioPharm International Editors
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
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 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 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 agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.
Apr 03, 2018
By BioPharm International Editors
The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
Apr 01, 2018
BioPharm International
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry.
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