What's new
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September 3, 2026
Regen.
New
English Translation of Review Report: Akuugo (Partial Change Approval)
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September 3, 2026
New
Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of Oral Drug Products (Early Consideration) posted.
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August 31, 2026
Devices
New
Available schedule for consultation by the Office of Software as a Medical Device updated
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August 28, 2026
Drug
IVD
CDx approved for identifying eligible patients (Updated)
