TPP biologics exclusivity compromise raises discussion

According to RAPS.org, the Trans-Pacific Partnership (TPP) recently came to a compromise that would “provide eight years of exclusivity to biologic drugs, or provide five years of exclusivity, plus up to three more years under a regulatory framework for the 12...

How to avoid 483 observations

In an In-Pharma article by Dan Stanton, Robert Fish discusses how to avoid 483 observations during audits. Fish, who served as FDA inspector for over 30 years, stressed the importance of knowing application details and training employees through mock inspections. In...

Pentagon working alongside Silicon Valley

The Pentagon recently contributed $75 million to an initiative called “Flexible Hybrid Electronics Manufacturing Innovation Hub” in Silicon Valley. According to PARC, the market for flexible electronics is growing exponentially and is expected to reach $45 billion...