A drugmaker convicted of bribery in China will have its products barred from being purchased by private and government-funded organizations for two years in the province where it is convicted. A second offense within five years will result in a two-year, nationwide ban. Read More

The number of drug recalls shot up 17 percent in 2013 compared to 2012, despite the FDA’s best efforts to promote quality-by-design programs and upgrades to facilities. Read More

The European Commission (EC) is threatening to take legal action against Italy, Poland, Slovenia and Finland for failing to implement the Falsified Medicines Directive, an EU-wide anti-counterfeit initiative that has been in effect since Jan. 2, 2013. Read More

To satisfy new Australian guidance on supplier qualification for raw materials, drugmakers need to stop using one-size-fits-all questionnaires and adopt screening methods that are specific to the products they are making. Read More

The FDA has hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More

2013 ushered in a trifecta of new compliance requirements for drugmakers around serialization and tracking, supplier quality and imports. Read More

The FDA’s unusual demand that an importer of active pharmaceutical ingredients (API) list the distributors that might sell finished product created with the API has sparked a lawsuit that could further complicate U.S. border control processes. Read More

When President Obama signed the Drug Quality and Security Act into law in November, it immediately preempted all state measures for track and trace and established one federal system for pharmaceuticals. Read More

With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More

The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More

The FDA has lifted a partial clinical hold on Cell Therapeutics’ blood cancer drug tosedostat, giving the green light for continuing mid-stage clinical trials. Read More