Biosimilar approval and adoption in the U.S. needs to be expedited
(By Carlos Sattler and Sheila Frame for STAT) Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999
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FDA approves new generic for valsartan
After multiple recalls of a certain generic valsartan medications, the U.S. Food and Drug Administration has approved a new generic
Read moreHidden FDA Reports Detail Harm Caused By Scores Of Medical Devices
(By Christine Jewett for Kaiser Health News) Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something
Read morePatients Question How FDA Approves Medical Devices
(By Blake Farmer, Nashville Public Radio and Kaiser Health News) There’s no doubt that surgically implanted medical devices can improve
Read moreFDA: Young-blood transfusions provide ‘no proven clinical benefit’ for aging, Alzheimer’s
(By Rebecca Robbins for STAT) The quest to rejuvenate aging people with the blood of young donors has generated paying
Read moreTrump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale
(By Sydney Lupkin and Jay Hancock for Kaiser Health News) The Trump administration has been trumpeting a huge increase in
Read moreFDA releases regulatory framework for digital health: 4 things to know
(By Jessica Kim Cohen for Becker’s Hospital Review) The FDA has drafted a new regulatory framework outlining how it wants to
Read moreGottlieb blasts high insulin prices, touts far-off new rules he says will spur competition in that market
(By Nicholas Florko for STAT) WASHINGTON — FDA Commissioner Scott Gottlieb blasted insulin makers Tuesday for what he called unacceptably
Read moreGovernment Investigation Finds Flaws In the FDA’s Orphan Drug Program
(By Sarah Jane Tribble and Sydney Lupkin for Kaiser Health News) The Food and Drug Administration has failed to ensure
Read moreIntensity, duration of drug shortages are spiking, FDA says
(By Alia Paavola for Becker’s Hospital Review) The FDA is not only seeing an increased incidence of drug shortages, there’s
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