FDA application pathways, expedited-review designations, exclusivity and patent mechanisms, and manufacturing process terms. Each entry is a definitive reference page, schema-marked as DefinedTerm, citation-grade.
FDA submission types and the abbreviated, supplemental, and biologic application routes that get a generic, branded, or biosimilar product to market.
Designations that accelerate development or review timelines: breakthrough therapy, fast track, priority review, accelerated approval, RMAT, project Orbis.
Market protection mechanisms: NCE exclusivity, 180-day exclusivity, orphan drug exclusivity, pediatric exclusivity, paragraph IV certification, patent term extension.
Manufacturing, inspection, and document-flow terms: GMP, DMF, CRL, eCTD, FDA inspection, meeting types, advisory committee.
The glossary tracks the questions sourcing, BD, and regulatory teams actually search for. Book a working session if you want a specific term added in the next refresh.