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April 1, 2024

GDUFA Paid Facilities List

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 […]
March 6, 2024

Emerging Technology Program

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 […]
March 6, 2024

Benefits of Emerging Technology Program

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

News from Emerging Technology Program (ETP)

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

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