title: Legal foundations of adaptive licensing.
abstract: In April 2012, MIT's Center for Biomedical Innovation and the European Medicines Agency (EMA) cosponsored a workshop on legal foundations of adaptive pharmaceuticals licensing. Past and present attorneys from the US Food and Drug Administration (FDA), the EMA, and Health Sciences Agency Singapore (HSA) found that existing statutes provided authority for adaptive licensing (AL). By contrast, an attorney from Health Canada identified gaps in authority. Reimbursement during initial phases of adaptive approaches to licensing was deemed consistent with existing statutes in all jurisdictions.
authors: Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA. oye@mit.edu
authors: K
authors: K
authors: Oye
authors: L G
authors: LG
authors: Baird
authors: A
authors: A
authors: Chia
authors: S
authors: S
authors: Hocking
authors: P B
authors: PB
authors: Hutt
authors: D
authors: D
authors: Lee
authors: L
authors: L
authors: Norwalk
authors: V
authors: V
authors: Salvatore
mesh_terms: D002170:Canada; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D008004:Licensure / Q000331:legislation & jurisprudence*; D014481:United States