A Pathway, Not A Shortcut: 505(b)(2) NDAs Have Longer Reviews Than NMEs
US FDA's argument that its review resources favor novelty/medical advances could be buttressed by Tufts Center for the Study of Drug Development analysis of (less novel) approvals using the streamlined 505(b)(2) NDA pathway.
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Keeping Track: US FDA Refuses To File Acorda, SteadyMed NDAs
Issues involving inspectional readiness and the drug master production record cited in agency's refusal to review Acorda's Inbrija in Parkinson's disease; SteadyMed faces request for additional design verification and validation testing for drug/device combo Trevyent in pulmonary arterial hypertension.
Emflaza's 505(b)(2) Pathway Review: Rare, But With Precedent
US FDA has relied on 505(b)(2) pathway to approve a small group of 'orphaned orphan' drugs – products without patent protection being used on an informal 'gray market' of personal importation and compassionate use protocols.
Novel Approvals Were Fewer But Faster At US FDA In 2016
While the total of 22 new molecular entities and therapeutic biologics approved in 2016 was lower than in recent years, the average time to approval was shorter than ever – thanks to historically high proportions of priority review agents and first-cycle approvals in the class.