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The 2nd Circuit Appeals Court says that the fact that FDA cleared a home pregnancy test with specific instructions on how it is to...[ Price : $8.95]
FDA clears a Heidelberg Engineering 510(k) to market its Spectralis OCT Glaucoma Module Premium Edition that is intended to provid...[ Price : $8.95]
FDA accepts for review a TherapeuticsMD NDA for Yuvvexy, an investigational bio-identical 17β-estradiol vaginal softgel capsu...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Option Care Enterprises, Jeffreys Drug Store, Sarkli/Repechage and ZO Skin Healt...[ Price : $8.95]
Alcon asks FDA to revise its Ciprodex product-specific guidance to eliminate any in vitro option to demonstrate bioequivalence.[ Price : $8.95]
A Tufts Center for the Study of Drug Development analysis says that FDA review time for diabetes drugs has increased in recent yea...[ Price : $8.95]
CDRH publishes 10 regulatory science priorities that will be its focus in FY 2017.[ Price : $8.95]
Reed Smith attorney James Beck reviews cases that explore the legal issues in proving causation in state-law product liability ina...