FDA warns Indias Reine Lifescience about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns Ei LLC about significant violations of CGMP in its manufacturing of finished pharmaceuticals.
FDA asks drug manufacturers to update their PDUFA 6 information and be aware of policy changes under PDUFA.
FDA says there are steps CDRH will take to promote improved servicing of medical devices without imposing new regulations that cant be justified by ob...
Healthcare IT News says two HHS cybersecurity alerts describe serious security flaws in Philips, GE, and Silex medical devices.
A West Virginia appeals court says its state law does not allow liability of a branded drug company for an injury caused by a generic version of the d...
FDA releases its latest batch of Warning Letters that includes Product Quest MFG and Reine Lifescience.
FDA posts a 5/15 proposed rule that, once finalized, would bring more transparency to the combination product regulatory process.