CDRH introduces its STeP safer technologies program.
FDA grants an orphan drug designation for its novel gene therapy for treating the CEP290 mutation associated retinal disease.
Federal Register notice: FDA revokes an emergency use authorization issued to Luminex for the xMAP MultiFLEX Zika RNA Assay.
Attorney Vernessa Pollard says that medical device software pre-certification may lead to greater post-market surveillance and data collection obligat...
PhRMA recommends changes to an FDA draft guidance on a benefit/risk framework for evaluating prescription opioids.
Attorney James Beck says attorneys should argue for preemption of failure-to-warn claims that covers any informational claims that demand substantive ...
Attorney Sara Koblitz says a California bill would presume that pay-for-delay settlements between branded and generic drug companies are anticompetiti...
Pharmaceutical Manufacturing Research Services asks the DC appeals court to reverse FDA rejection of its Roxicodone abuse-deterrent prescription opioi...