FDA warns Oxford Medical Instruments that it is marketing unapproved and misbranded new drugs and claiming they can treat Covid-19.
Federal Register notice: FDA revises its regulations to reflect changes to the agencys organizational structure, including the reorganization of the O...
Federal Register notice: FDA seeks comments on an information collection extension for CVM dispute resolution procedures.
FDA publishes a guidance with its compliance policy on the retention of reserve samples of the test article and reference standard used in bioavailabi...
FDA warns a Singapore-based Web site that it is selling an unapproved and misbranded colloidal silver drug product intended to treat Covid-19.
CDER issues a MAPP on policies and procedures for notifying NDA and BLA applicants about ARIA safety studies conducted in the Sentinel system.
FDA announces an 11/13 public workshop on infections related to orthopedic devices and appropriate mitigation measures for protecting and promoting pu...
FDA releases its latest batch of Warning Letters that includes AkivaMed, Oxford Medical Instruments and SilveryGuy.