Attorney Sara Koblitz says it shouldnt have required litigation to force FDA to respond fully to issues raised by Vanda over animal trials for its tra...
Oregon attorney general Ellen Rosenblum says Pfizer is paying $975,000 to settle state charges it distributed misleading marketing materials and coupo...
A Dallas federal court sentences a Shanghai, China business owner to 18 months imprisonment and one year of supervised release in connection with a sc...
Two stakeholders ask FDA for clarifications and changes to a draft guidance on content of premarket submissions for managing cybersecurity in medical ...
Federal Register notice: FDA makes available a final guidance entitled Pediatric HIV Infection: Drug Product Development for Treatment.
HHSs Centers for Medicare & Medicaid Services submits to OMB for review a proposed rule to require including drugs list prices in direct-to-consumer a...
New York University researchers say they have developed nanoscale protein micelles that can both deliver drug therapy and be tracked by MRI.
CDRH director Jeffrey Shuren updates work of the National Evaluation System for health Technology in assessing how real-world evidence can be used to ...