FDA to pursue pharma exec prosecutions; Portal aids cold-chain audits;

> Following GAO criticism of its industry performance-standards development, the FDA says it plans to "thoughtfully" invoke its seldom-used "strict liability" tool to prosecute corporate executives for criminal actions within their companies. Article

> The Kelsius Cold Chain Portal sits atop a SaaS-based wireless sensor network, providing data from various operational points to a repository that can format audit trail documentation. Release

> VGXI has nearly doubled its cGMP plasmid manufacturing facility in Texas to meet demand for our research and manufacturing services. Announcement

> India is claiming title as the world's top exporter of generic medicines. Article

> The FDA has given its thumbs-up to the facility intended for commercial production of Cell Therapeutics' non-Hodgkin's lymphoma treatment pixantrone, expected to undergo FDA review this month. Release

Suggested Articles

South Korea’s Celltrion, which has a massive biologics site in Songdo, has decided it is time to build some operations in China.

WuXi Biologics is taking control of a Bayer plant in Germany and agreed it could serve as a backup facility for supply of hemophilia drug Kovaltry.

A Chinese OTC drugmaker gets the distinction of ringing in the new year as the first company to be slapped with an FDA warning letter.