Standards/Regulations

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.
Apr 01, 2018
BioPharm International
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
Apr 01, 2018
BioPharm International
Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Mar 29, 2018
Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
Mar 23, 2018
By BioPharm International Editors
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
Mar 20, 2018
By BioPharm International Editors
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
Mar 20, 2018
By BioPharm International Editors
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
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