April 16, 2024

Completed BsUFA III Deliverables

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review […]
April 16, 2024

Pediatric Tracking Requirements Under FDAAA

The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]
April 16, 2024

Data Standards Catalog

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food […]
April 16, 2024

Guidance Snapshot Pilot

Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language to support transparent communication and dissemination of FDA guidance […]
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