FDA issues a draft guidance answering commonly asked questions about the drug product Orange Book.
An FDA letter reminds healthcare staff to use the correct decontamination cycle associated with certain models of Advanced Sterilization Products Ster...
FDA solicits information from a wide variety of sources on improving the design, conduct, and completion of rare disease clinical trials.
CDER encourages industry sponsors to incorporate the Centers naloxone model drug facts label in development plans for over-the-counter approval of the...
Medtronic recalls (Class 1) its HeartWare Ventricular Assist Device Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft of th...
FDA releases a reference panel to support its evaluation of diagnostic tests for Covid-19.
Academic researchers propose a drug quality system to differentiate among products and manufacturers.
FDA posts upcoming and recent eMDR system enhancements.