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The FDA is encouraging drugmakers to work together to get agency qualification for drug development tools (DDTs), which can then be used to aid in development and review of multiple companies’ drugs. Read More
The FDA is approving fewer breakthrough therapy designation requests from drugmakers and agency officials say the need for more evidence of effectiveness is the reason. Read More
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
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
The FDA is maintaining pressure on Pfizer subsidiary Meridian Medical Technologies, a maker of drug auto-injectors, to improve quality at its Missouri plants. 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