A review of Olympus presentations to the U.S. FDA over its duodenoscopes suggests the Japan-based medical-device maker may have been "hoist with his own petard" in its attempt to have cleaning guidelines watered down.
The FDA has released draft guidance on electronic informed consent. And the scope is as broad as trial sponsors' imaginations, with the FDA opening the door to the use of podcasts, "biological recognition devices" and any other method that conveys adequate, understandable information and captures informed consent.
The FDA just approved a first-of-its-kind blood purifier to treat a complication of kidney failure under its pathway for medical devices that treat rare conditions.
When the FDA rejected AcelRx's drug/device Zalviso for pain last summer, the biotech said no new trials were required--suggesting it could be back in front of regulators quickly--and investors cut the value of shares by more than 30%. This morning the biotech said a new study is needed after all, and investors responded by sending shares down by more than 40%.
Sun Pharmaceuticals issued a recall of 5,322 bottles of one of its eye drugs after particulate matter was found in a test batch.
One of the three Japan-made endoscopes associated with recent superbug outbreaks--the duodenoscope made by Olympus--did not have FDA approval, CNN reports.
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.
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.
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.
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."