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.
The Justice Department charges Teva with paying illegal kickbacks by funding foundations to channel company money to pay Medicare co-pays for patients...
FDA grants AstraZeneca a priority review for its supplemental BLA for Imfinzi (durvalumab) and a new four-week, fixed-dose regimen for treating approv...