Standards & Regulations

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The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.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.
Mar 20, 2018
By BioPharm International Editors
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
Mar 16, 2018
By BioPharm International Editors
The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
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