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Digital Health Technologies

by | Jul 31, 2025 | News

Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial...

Novel Excipient Review Pilot Program

by | Jul 31, 2025 | News

FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive...

ISTAND Program Submission Process

by | Jul 31, 2025 | News

Submission ProcessThe 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or...

GDUFA User Fee Rates Archive

by | Jul 30, 2025 | News

GDUFA User Fee Rates Archive | FDA In this section: FDA User Fee Programs Home For Industry FDA User Fee Programs GDUFA User Fee Rates Archive FDA User Fee Programs Generic Drug User Fee Rates for Fiscal Year 2025Generic Drug User Fee Rates for Fiscal Year 2024Generic...