Regulatory Beat

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.
Apr 01, 2013
BioPharm International
Opioid abuse generates calls for efforts to curb distribution.
Mar 01, 2013
BioPharm International
Vaccine development is benefiting from manufacturing advances.
Feb 01, 2013
BioPharm International
Shortages spur efforts to overhaul manufacturing oversight.
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