[ Price : $8.95]
Federal Register notice: FDA withdraws approval of four NDAs from multiple sponsors because they repeatedly failed to file require...[ Price : $8.95]
FDA Webview editor Jim Dickinson analyzes the evolving legacy of departing CDRH director Jeff Shuren and his hand-picked interim s...[ Price : $8.95]
A 2023 inspection at South Koreas C&T Dream Co. leads to a nine-observation FDA Form-483 that cites significant GMP deviations.[ Price : $8.95]
Gilead Sciences recalls one lot of Veklury (remdesivir) for injection 100 mg/vial, after it received a customer complaint about th...[ Price : $8.95]
FDA has appointed industry veteran and consultant Ross Segan as CDRH Office of Product Evaluation and Quality director, replacing ...[ Price : $8.95]
Ideaya Biosciences says it is advancing darovasertib into a Phase 3 trial following positive interim Phase 2 clinical trial data o...[ Price : $8.95]
Federal Register notice: FDA makes available three draft guidances for its Accreditation Scheme for Conformity Assessment Program.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Chemical Analysis for Biocompatibility Assessment of Medica...