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Federal Register notice: FDA makes available a final guidance on pharmacokinetic-based criteria for supporting alternative dosing ...[ Price : $8.95]
FDA asks Oncopeptides to withdraw the accelerated approval of multiple myeloma therapy Pepaxto (melphalan flufenamide) after a con...[ Price : $8.95]
An Associated Press story says FDA has granted fewer accelerated approval NDAs/BLAs after taking new steps to tighten control over...[ Price : $8.95]
Former FDA commissioners Scott Gottlieb and Mark McClellan call on Congress to promptly pass the VALID Act to modernize FDA regula...[ Price : $8.95]
FDA posts a final guidance on pharmacokinetic-based criteria used to supporting alternative dosing programmed cell death receptor-...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled E19 A Selective Approach to Safety Data Collection in Speci...[ Price : $8.95]
Contract testing laboratory Valisure relinquishes its regulatory testing ability after a recent FDA inspection raised testing issu...[ Price : $8.95]
FDA updates a January safety communication about the use of Endologix AFX endovascular grafts for treating patients with abdominal...