[ Price : $8.95]
CDRH associate director Suzanne Schwartz says medical device manufacturers should build cyber security into their devices at the d...[ Price : $8.95]
FDA says an ICH guidance on genomic sampling and data has passed Step 4 and is being implemented.[ Price : $8.95]
Attorney Rachel Weil says a New Your federal court has ruled that a liability suit against Bayer over its Essure birth control dev...[ Price : $8.95]
FDA approves Amgens Mvasi, a biosimilar to Genentechs Avastin, for treating multiple forms of cancer.[ Price : $8.95]
FDA issues a guidance to facilitate study designs establishing performance characteristics of in vitro diagnostic devices intended...[ Price : $8.95]
FDA approves AstraZenecas asthma therapy Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol 160/4.5 microgram...[ Price : $8.95]
FDA permits under its de novo process the marketing of the first mobile medical application to help treat substance use disorders.[ Price : $8.95]
FDA releases a draft guidance to help industry know when a microneedling product is legally considered a medical device subject to...