This list contains GDUFA facility payments received by the Agency. The following table explains the terms used in the list: Column Description Fiscal Year The Fiscal Year […]

Docket Number: FDA-2014-D-0092 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking […]

FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. Pharmaceutical companies may have concerns that developing such technologies could result […]

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. […]

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 […]

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 […]

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 […]

OSI Metrics Overview | FDA In this section: Center for Drug Evaluation and Research | CDER Home About FDA FDA Organization Center for Drug Evaluation and […]

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 […]