FDA says it is concerned that Section 505(q) of the Federal Food, Drug, and Cosmetic Act does not discourage submission of citizen petitions intended ...
FDA clears a Konica Minolta Healthcare Americas 510(k) for its Dynamic Digital Radiography device.
FDA takes additional steps intended to improve safety of surgical staplers and staples for internal use.
Three stakeholders recommend changes to increase transparency and clarity in an FDA draft guidance on competitive generic therapies.
FDA warns Abaxis about violations in its manufacturing and distribution of in-vitro diagnostic reagents.
CDER drug advertising researchers say new studies are needed to consider the changing online presence of prescription drug promotion.
FDA clears an AliveCor 510(k) for its KardiaMobile consumer electrocardiogram (ECG) technology for expanded use to detect and show ECG results for bra...
FDA releases its latest batch of Warning Letters that includes one medical product company Abaxis.