FDA says further study has indicated no increased risk of prostate cancer for users of Comtan or Stalevo to treat Parkinsons disease.
Dalhousie University professor Matthew Herder says FDA appears resigned to and resistant to criticism of its increasing regulatory reliance on postmar...
FDA releases its latest batch of Warning Letters that includes Emcure Pharma, Lantech Pharma, Spectrum Laboratory Products and Talon.
FDA clears a DynoSense 510(k) for its Vital Signs Measuring System, a cloud-based vital signs measuring and recording platform.
FDA publishes a guidance with recommendations to assist companies that want to include child-resistant packaging statements in their drug product labe...
Ropes & Gray attorneys Kellie Combs and Sarah Blankstein say companies are not likely to get heavily involved in real-world evidence studies for regul...
FDA clears a SpineWelding 510(k) for its Elaris Pedicle Screw System, which is intended to provide immobilization and stabilization of spinal segments...
A group of U.S. Senate Democrats urge FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting manipulated data in its BLA for re...