PhRMA recommends changes to an FDA draft guidance on a benefit/risk framework for evaluating prescription opioids.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...
FDA clears a Sofwave Medical 510(k) its Sofwave system, indicated for treating facial lines and wrinkles.
FDA gives Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-Eluting Balloon for treating below-the-knee peripheral artery di...
FDA warns SC Johnson (formerly Deb USA) about CGMP and other violations in its production of finished pharmaceuticals.
FDA accepts for priority review a Merck BLA for its investigational Ebola vaccine.