Federal Register notice: FDA makes available a final guidance entitled Classification of Products as Drugs and Devices & Additional Product Classifica...
An EY Pulse of the Industry 2017 report urges medtech companies to act now to address cybersecurity issues rather than waiting for safety notification...
FDA denies a US WorldMeds petition asking for specific conditions on any applicant proposing a drug-device combination with apomorphine for use in the...
The Justice Department advises the 3rd Circuit Court of Appeals that a federal district court failed to recognize that some state tort claims are not ...
FDA commissioner Scott Gottlieb says the agencys new Pre-Cert for Software pilot program is moving forward with the selection of nine company particip...
FDA releases its latest batch of Warning Letters that includes Shandong Vianor Biotech and Vicare International.
FDA accepts for review a TherOx Inc. PMA for its Supersaturated Oxygen Therapy system, intended for use in reducing infarct size and improving outcome...
FDA accepts for review an Eisai supplemental NDA for Lenvima (lenvatinib) for (XXX DELETE XXX)use in first-line treatment of patients with hepatocellu...