FDA guidance on outsourcing facilities and 503A pharmacies.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6065493 | PMC |
Expert Opin Drug Saf
January 2025
Shaoxing Yuecheng District People's Hospital, Shaoxing, China.
Background: Brivaracetam (BRV) is a novel drug for the treatment of epilepsy. This study aimed to detect and characterize adverse events (AEs) associated with BRV from the first quarter of 2016 to the second quarter of 2024 using the U.S.
View Article and Find Full Text PDFBackground: The use of automated insulin delivery (AID) devices is now widespread in the management of type 1 diabetes (T1D), being used for younger and older children, adolescents and adults. The integration of insulin pumps with continuous glucose monitors (CGM) and smart management software in AID systems has significantly improved glycemic management compared to the separate application of each diabetes technology. The efficacy of AID systems has been demonstrated in randomized controlled trials (RCTs) but it is their application in real-world studies that fully demonstrates their impact for people with T1D.
View Article and Find Full Text PDFStat Med
February 2025
U.S. Food and Drug Administration, Silver Spring, Maryland.
The recent U.S. Food and Drug Administration guidance on complex innovative trial designs acknowledges the use of Bayesian strategies to incorporate historical information based on clinical expertise and data similarity.
View Article and Find Full Text PDFDrug Saf
January 2025
Department of Public Health Pharmacy and Management, Sefako Makgatho Health Sciences University, Pretoria, South Africa.
Introduction: The COVID-19 pandemic accelerated new vaccine development. Limited safety data necessitated robust global safety surveillance to accurately identify and promptly communicate potential safety issues. The African Union Smart Safety Surveillance (AU-3S) program established the Joint Signal Management (JSM) group to support identification of potential vaccine safety concerns in five pilot countries (Ethiopia, Ghana, Kenya, Nigeria, South Africa), accounting for approximately 35% of the African population.
View Article and Find Full Text PDFPurpose: To provide updated guidance regarding neoadjuvant chemotherapy (NACT) and primary cytoreductive surgery (PCS) among patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (epithelial ovarian cancer [EOC]).
Methods: A multidisciplinary Expert Panel convened and updated the systematic review.
Results: Sixty-one studies form the evidence base.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!