Gilead gets 10-page Form 483; UPS opens China distribution; India government defends industry;

> Here is the 10-page Form 483 report for an April inspection of a Gilead Sciences ($GILD) plant that resulted in the and FDA complete response letter holding up approval of two of its drugs. Document

> UPS has opened a new 22,000-square meter pharmaceutical distribution facility in Hangzhou, Zhejiang Province, China. Release

> CPhI Worldwide has named a panel of 6 experts to report on trends in drug manufacturing, ahead of the annual meeting in Germany this year. Release

> The Congressional Budget Office has put some estimated costs to proposed legislation that would set up a drug track and trace system in the U.S. Report

> Drug regulators in India are starting inspections to meet a July 2 deadline for all drugs imported into the EU to be certified that they meet EU standards. Report

> The USP has delayed implementation of its new chapters on elemental impurities limits and procedures until it can be aligned with rules from the ICH. Report

And Finally... India's government has put out a statement defending the generic drug business following U.S. regulatory action against Ranbaxy Laboratories and Wockhardt. Story

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.