March 6, 2024
The Emerging Technology Program serves as an entry point for new technologies that will potentially be included in a regulatory filing for a specific drug product. […]
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 […]
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