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July 02, 2013
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
June 02, 2013
Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
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.
Companies can use metrics as a tool to help drive positive change and quality process improvements.
An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.
May 02, 2013
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
FDA faces budget crunch; Supreme Court hears key cases
April 02, 2013
Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.