FDA’s Sentinel Safety Surveillance Could Ease Phase IV Study Burden
Executive Summary
FDA recognizes its Sentinel post-market safety surveillance project could help answer some questions that typically would be explored in Phase IV studies
You may also be interested in...
FDA Post-Market Safety Efforts Won’t Be Impacted By Sentinel In Near Term
FDA's Sentinel post-market safety monitoring project will augment, not replace, the agency's current repertoire of post-market activities and requirements for drugs, Center for Drug Evaluation and Research Director Janet Woodcock emphasized
FDA Post-Market Safety Efforts Won’t Be Impacted By Sentinel In Near Term
FDA's Sentinel post-market safety monitoring project will augment, not replace, the agency's current repertoire of post-market activities and requirements for drugs, Center for Drug Evaluation and Research Director Janet Woodcock emphasized
FDA Amendments Act’s One-Year Anniversary: For Better Or Worse
At the one-year anniversary of the FDA Amendments Act, the agency's record is mixed in meeting its increased responsibilities and authorities the law requires