Regulatory Beat

Sep 01, 2013
BioPharm International
New FDA supply chain policies aim to strengthen inspection and oversight processes.
Sep 01, 2013
BioPharm International
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
Sep 01, 2013
BioPharm International
Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.
Aug 01, 2013
BioPharm International
FDA funds research to further development of innovative generics, while working to address review and approval issues.
Aug 01, 2013
BioPharm International
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
Jul 01, 2013
BioPharm International
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
Jun 01, 2013
BioPharm International
Companies can use metrics as a tool to help drive positive change and quality process improvements.
Jun 01, 2013
BioPharm International
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
Jun 01, 2013
BioPharm International
Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
May 01, 2013
BioPharm International
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
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