Cover: Thomas Cosgrove, director of FDA’s Office of Manufacturing Quality discusses his work to protect patients from the risks posed by poor drug quality. Data integrity, he says, is a big part of the solution.
Joe Famulare, ISPE Board Chair, weighs in on compliance, quality metrics, and how new technology is changing the industry. He also sat down with a panel of medical experts as part of an national radio broadcast to discuss drug shortages.
Thirteen life sciences companies were among MIT Technology Review’s “50 Smartest Companies for 2015,” a much more impressive showing than in previous years, mostly for pioneering technologies that can tackle challenging illnesses.
SPECIAL REPORT: Our six-part special report explores this multifaceted subject, describing the desired state, identifying red flags, and enumerating best practices. Our experts define the strategies that drive prevention, detection, and response: administrative and technical controls, effective review processes, critical success factors, and corporate training to encourage integrity.
Jaywant Pawar, Vinod S. Gokarna, Vineeta D. Deshpande, and Purnima D. Amin
Humberto Vega and Ricardo Rivera