dbtreg_fdaLevel 1

US FDA Regulatory Pathways

GET/api/v1/systems/domain_biotech_regulatory/nodes/dbtreg_fda

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dbtreg_fda_510k510(k) Premarket Notification for medical devices

dbtreg_fda_blaBLA (Biologics License Application) for biologics

dbtreg_fda_bpciBiosimilar pathway (BPCI Act, 351(k) applications)

dbtreg_fda_euaEUA (Emergency Use Authorization) pathway

dbtreg_fda_ndaNDA (New Drug Application) for small-molecule drugs

dbtreg_fda_pmaPMA (Premarket Approval) for high-risk devices

Cross-system equivalences2

NAICS 2022

3254Pharmaceutical and Medicine Manufacturingbroad 5417Scientific Research and Development Servicesbroad

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