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Consultants RMS suggests ways that companies can reduce the impact and risk of FDA complete response letters.[ Price : $8.95]
Former FDA chief counsel Peter Barton Hutt passes away at the age of 91.[ Price : $8.95]
Boston Scientific recalls all unused spinal cord stimulator Infinion CX Leads after determining that the lead body may experience ...[ Price : $8.95]
CDRH issues an early alert based on a Draeger letter to customers recommending certain VentStar Resus Neo hoses (breathing circuit...[ Price : $8.95]
FDA warns Indias Shoolin Pharma Chem that it is producing active pharmaceutical ingredients in insanitary conditions and with sign...[ Price : $8.95]
FDA orders a Boxed Warning for American Regents Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophos...[ Price : $8.95]
Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an i...[ Price : $8.95]
CDRH issues an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain ki...