ingentaconnectGray Sheet
Upcoming: Drug Development Considerations for Empiric Antibacterial Therapy in Febrile Neutropenic Patients 美东时间2024年4月23日,FDA将举办一场题为“发热性中性粒细胞减少症(febrile neutropenia ,FN)患者经验性抗菌治疗的药物开发注意事项”的公开研讨会。该研讨会的目的是讨论临床试验设计以及与开发治疗FN的抗菌...
1.FDA Performance Tracker:User Fee Goal Dates.Pink Sheet.Retrieved on 20.03.2024.2.FDA Performance Tracker:Novel CDER Approvals.Pink Sheet.Retrieved on 20.03.2024.3.Shui-Jezierski,A.Upcoming market catalysts in Q2 2024.Nature Reviews Drug Discovery.13.03.2024.声明:本内容仅用作医药行业信息传...
在2024年4月11日于Bethesda, MD举行的仿制药论坛(Generic Drug Forum,GDF)上,FDA药品质量办公室(Office of Pharmaceutical Quality,OPQ),药品生产评估办公室(Office of Pharmaceutical Manufacturing Assessment,OPMA)副主任Derek Smith表示,FDA 已通过其批准前检查(preapproval inspection,PAI)计划对生产设施进行了 20 多...
Upcoming: Drug Development Considerations for the Treatment of Congenital Cytomegalovirus Infection and Neonatal Enterovirus Infection 美东时间2024年5月7日到8日, FDA将举办一场题为“治疗先天性巨细胞病毒(Congenital Cytomegalovirus, CMV)感染和新生儿肠道病毒感染的药物开发”的公开研讨会。该研讨会的目的是讨论...
1.FDA Performance Tracker:User Fee Goal Dates.Pink Sheet.Retrieved on 20.03.2024. 2.FDA Performance Tracker:Novel CDER Approvals.Pink Sheet.Retrieved on 20.03.2024. 3.Shui-Jezierski,A.Upcoming market catalysts in Q2 2024.Nature Reviews Drug Discovery.13.03.2024....
1. Drug: Betibeglogene autotemcel Companies: bluebird bio Indication(s): Beta thalassemia One of the major gene therapy developers to watch in 2022 is bluebird bio. The company has two gene therapies which are expecting FDA approval this year. Betibeglogene autotemcel (beti-cel) is a cell...
“We are pleased to confirm the acceleration of the [fam-] trastuzumab deruxtecan clinical development programme for this potential indication in patients with HER2 positive metastatic breast cancer pretreated with T-DM1 ahead of schedule,” said Antoine Yver, MD, MSc, Executive Vice President and...
1. Drug: Betibeglogene autotemcel Companies: bluebird bio Indication(s): Beta thalassemia One of the major gene therapy developers to watch in 2022 is bluebird bio. The company has two gene therapies which are expecting...
Human drug sponsors may now source cannabis regulated as a Schedule I controlled substance from other DEA-authorized growers. Human drug sponsors should consider the recommendations in FDA’s final guidance,“Botanical Drug Development” (Dec. 2016). Importantly, the agency does not recommend relying...