Federal Register notice: FDA makes available a draft guidance #210 entitled The Index of Legally Marketed Unapproved New Animal Drugs for Minor Specie...
Federal Register notice: FDA makes available the safety and effectiveness summaries of recent PMAs approved by CBER.
CDRH associate director Suzanne Schwartz says medical device manufacturers should build cyber security into their devices at the design stage.
FDA says an ICH guidance on genomic sampling and data has passed Step 4 and is being implemented.
Attorney Rachel Weil says a New Your federal court has ruled that a liability suit against Bayer over its Essure birth control device is preempted by ...
FDA approves Amgens Mvasi, a biosimilar to Genentechs Avastin, for treating multiple forms of cancer.
FDA issues a guidance to facilitate study designs establishing performance characteristics of in vitro diagnostic devices intended for detection or de...
FDA approves AstraZenecas asthma therapy Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol 160/4.5 micrograms to reduce exacerba...