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Drugmakers in Europe are calling for the establishment of a new clinical trial portal and database, rather than modifying existing systems, to meet requirements for a single, streamlined submission process for clinical trial applications. Read More
Drug sponsors should find a more comprehensive way of recording and integrating patient outcomes data into their efficacy analyses, says a top FDA official who notes the lack of such data often presents a roadblock to making regulatory decisions. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483. Read More
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
Drugmaker Chimerix said it may soon start testing its broad-spectrum antiviral drug brincidofovir against the Ebola virus, after the FDA this week approved the company’s emergency investigational new drug application. Read More
PhRMA is asking a D.C. federal court to once again strike down a price discount mandated by HHS for orphan drugs, when used to treat non-rare conditions at certain covered hospitals. Read More