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Elizabeth Orr
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Latest From Elizabeth Orr
US FDA, NIST Join Forces To Improve Manufacturing, Prevent Drug And Device Shortages
The focus on innovative manufacturing will also include a new clearinghouse to share info about advanced manufacturing technology within the US agency’s device center.
US FDA Announces 99 New Or Updated Consensus Standards
The updates reflect changes to standards on medical electrical equipment and a wide range of device types.
Fines, But No Prison Time For Ex-Acclarent Execs
The sentences are the latest chapter in a long-running off-label marketing case.
FDA, NIST Join Forces To Improve Manufacturing, Quell Device Shortages
The focus on innovative manufacturing will also include a new clearinghouse to share info about advanced manufacturing technology within the US agency’s device center.
Government Report Outlines Costs, Savings Of Major Regs
The US HHS was responsible for the most major regulations over the last few years of any agency, an OMB report shows.
US FDA Panel To Take Up Lutonix DCB Catheter For Lower-Leg Use Next Month
If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.