CBERs Office of Compliance and Biologics Quality sends an untitled letter to R3 Stem Cell because its Web site promotes its regenerative stem cell the...
FDA approves a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjun...
FDA solicits comment on a plan to modify packaging of some immediate release opioids in fixed-quantity, unit-of-use blister packs.
CDER Office of Surveillance and Epidemiology director Gerald Dal Pan says the number of drug adverse event reports set a record in 2018 because more d...
Federal Register notice: FDA determines that AbbVies Lupron (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn from sale for reasons of sa...
FDA announces a 7/17 public workshop entitled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.
FDA approves an Astellas Pharma supplemental NDA to update the U.S. product labeling for Xospata (gilteritinib) to include final analysis data from th...
Five FDAers working in oncology say there is a need for more patient-friendly language to use in communicating oncology drug risks and benefits.