Regulatory Beat

Dec 01, 2013
BioPharm International
New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
Nov 01, 2013
BioPharm International
Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.
Oct 01, 2013
BioPharm International
Manufacturing standards are considered key to preventing drug recalls and shortages.
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.
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