FDA says its Division of Drug Information pharmacists are available to answer consumer questions about taking drugs.
FDA updates possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products.
FDA tells a Texas federal court it needs until 2076 to respond to a Public Health and Medical Professionals for Transparency request for information o...
FDA says AB Science can resume enrollment of ALS patients in a Phase 3 study of masitinib.
FDA grants fast track designation to a Zentalis investigative drug for uterine serous carcinoma.
The Alzheimers Association and other stakeholders are launching a national registry for Alzheimers diagnostic and treatment information.
Two Wiley Rein attorneys suggest ways companies could approach the new FDA section 510(j)(3) drug reporting requirement.
SterRx recalls 240 lots of various drug products within their expiry period due to equipment and process issues that could lead to a lack of sterility...