March 6, 2024
Criteria to Participate in the Emerging Technology Program To qualify for participation in the Emerging Technology Program, technologies need to: Have the potential to improve product […]
March 6, 2024
Benefits to participating in the Emerging Technology Program. Participants in the program can expect: Pre-submission face-to-face interactions with ETT members and review staff to answer technical […]
March 6, 2024
Emerging Technology Program Graduates its First Technology The Emerging Technology Program (ETP) is proud to announce it graduated its first technology, Continuous Direct Compression (CDC) on […]
March 6, 2024
OSI Metrics Overview | FDA In this section: Center for Drug Evaluation and Research | CDER Home About FDA FDA Organization Center for Drug Evaluation and […]
March 6, 2024
On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive […]
March 6, 2024
An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a […]
March 6, 2024
TOPLINE: Sex-specific differences in kidney metabolism may underlie differences in diabetic kidney disease (DKD) outcomes in men and women, new research suggests. METHODOLOGY: To identify sex-based […]
March 6, 2024
The US Food and Drug Administration (FDA) has approved the first biosimilar to denosumab, denosumab-bddz (Wyost/Jubbonti). The biosimilar was also granted interchangeability status, which allows pharmacists […]
March 6, 2024
Overview of FDALabel DatabaseFDALabel Database AccessPotential UsersWhat is Included in Drug Labeling?Database FeaturesLive Queries Updates and StatisticsUser GuidesAdditional InformationOther ResourcesReferencesContact InformationDisclaimer FDALabel Version 2.8.2 Provide feedback or request […]