Three stakeholders recommend changes to increase transparency and clarity in an FDA draft guidance on competitive generic therapies.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.
FDA says it has continued confidence in the safety and effectiveness of the measles, mumps, and rubella vaccine, urging consumers on the importance of...
FDA grants a de novo clearance to NeuroSigma for its prescription-only Monarch external Trigeminal Nerve Stimulation System, the first medical device ...
Federal Register notice: FDA seeks comments on an information collection extension for Deeming Tobacco Products To Be Subject to the FD&C Act (OMB Con...