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Federal Register notice: FDA revokes an emergency use authorization issued to Luminex for the xMAP MultiFLEX Zika RNA Assay.[ Price : $8.95]
Attorney Vernessa Pollard says that medical device software pre-certification may lead to greater post-market surveillance and dat...[ Price : $8.95]
PhRMA recommends changes to an FDA draft guidance on a benefit/risk framework for evaluating prescription opioids.[ Price : $8.95]
Attorney James Beck says attorneys should argue for preemption of failure-to-warn claims that covers any informational claims that...[ Price : $8.95]
Attorney Sara Koblitz says a California bill would presume that pay-for-delay settlements between branded and generic drug compani...[ Price : $8.95]
Pharmaceutical Manufacturing Research Services asks the DC appeals court to reverse FDA rejection of its Roxicodone abuse-deterren...[ Price : $8.95]
FDA clears a Sofwave Medical 510(k) its Sofwave system, indicated for treating facial lines and wrinkles.[ Price : $8.95]
FDA gives Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-Eluting Balloon for treating below-the-knee ...