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FDA

Latest Headlines

Latest Headlines

As 'superbug' reports increase, Olympus says duodenoscope design modification did not require FDA nod

One of the three Japan-made endoscopes associated with recent superbug outbreaks--the duodenoscope made by Olympus--did not have FDA approval, CNN reports.

Need to know which drugs are in short supply? FDA has an app for that

To help healthcare providers more easily track drug shortages, the FDA has released a mobile app that will allow anyone to use a smartphone to look up current shortages and discontinuations as well as shortages that have been resolved.

FDA campaign against use of foreign-made cancer drugs rolls up another doctor

The FDA and Justice Department has extracted a half-million-dollar settlement from a California oncologist who is among doctors found to be buying unapproved cancer drugs and then charging state and federal programs for FDA-approved treatments. The agreement comes just weeks after a Kentucky doctor pleaded guilty to charges of doing the same thing.

FDA calls for heart, stroke warnings on 'Low T' meds

The FDA threw another hurdle in the path of drugmakers selling "Low T" drugs, requiring manufacturers to update labels to warn that the meds could increase the risk of heart attacks and strokes and should not be prescribed to treat age-related symptoms.

FDA requires new labeling on insulin pens to ward off spread of infections

The FDA is taking action to ensure that multidose insulin pens do not spread diseases by requiring the injectable devices to display the warning "For single patient use only."

Three Japanese device firms slapped with U.S. FDA queries on possible 'superbug' link

Three Japanese companies known more for their cameras than medical devices have been called on the U.S. FDA carpet to explain why their medical scopes may be associated with at least two "superbug" deaths.

Ranbaxy bid to regain marketing approval for key generics shot down by federal judge

A Ranbaxy Laboratories effort to have two of its drugs returned to the U.S. FDA's marketing-approval list was quashed when a U.S. district judge dismissed the suit at the request of the agency.

FDA warns manufacturer of failing to report corrections to its device disinfection system

The FDA has issued a stern warning to infection control specialist Cenorin, advising the company to correct violations such as failing to notify the FDA of a correction sent to users of its medical device disinfection system.

New Jersey compounder indicted over unsanitary manufacturing

The FDA has decided that not only were the operations of New Jersey-based Med Prep Consulting unsterile, they were illegal.

FDA in midst of updating endoscope labels implicated in 'superbug' infections

The U.S. Food and Drug Administration is working to update the labels for duodenoscopes linked to the recent "superbug" outbreak that were inadequately cleaned, according to a Reuters report.