FDA Week - 11/16/2018

FDA Hopes Sterile Injectable Data Project Will Stem Shortages

By David Roza / November 12, 2018 at 2:21 PM
In its latest bid to tackle the problem of drug shortages, FDA plans to collect and analyze the information it gathers from inspections of sterile injectable drug manufacturing facilities in hopes of spotting and resolving problems before shortages occur. The agency hopes to expand the approach to its inspections of all dosage forms of drugs in the next two years. “With better and more consistent oversight of these manufacturing facilities, we hope to be able to spot problems earlier and...


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