FDA Approvals - FDA To Speed Generic Drug Application Reviews (Medical News Today)
FDA To Speed Generic Drug Application Reviews (Medical News Today)
FDA on Thursday announced that it is implementing a number of changes to speed the approval process for generic drugs and reduce a backlog of more than 1,000 generic drug applications, the AP/Chicago Tribune reports. [click link for full article]
FDA approves fewer Indian copycat drugs (Indian Express via Yahoo! India News)
The number of approved abbreviated new drug applications (ANDAs) filed by Indian pharmaceutical companies-which have aggressively launched copycat versions of off-patent drugs in the US market-has declined dramatically in the last four months. Generic companies file ANDAs to obtain marketing approvals for drugs whose patents expire in the United States, the world's largest pharma market. Last ...