FDA approves a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is intended to improve implantation procedures for endov...
Two drug companies comment on an FDA draft guidance on antibacterial therapies.
Federal Register notice: FDA makes available a final guidance entitled Orange Book Questions and Answers.
Federal Register notice: FDA makes available a final guidance entitled Failure To Respond to an ANDA Complete Response Letter Within the Regulatory Ti...
Medexus Pharmaceuticals says its medac licensor has resubmitted its NDA for treosulfan, indicated for combination use with fludarabine as a preparativ...
Philips discusses proposed terms of a consent decree with FDA involving the companys troubled Respironics unit and its ventilators, continuous positiv...
Medical device maker Biotronik pays $13 million to resolve allegations that it violated the False Claims Act by causing false claims to be submitted t...
Federal Register notice: FDA makes available a draft guidance entitled Conducting Remote Regulatory Assessments Questions and Answers.