Legal foundations of adaptive licensing

Clinical Pharmacology and Therapeutics

Volumn 94, Issue 3, 2013, Pages 309-311

  Oye, K ^a   Baird, L G ^a   Chia, A ^b   Hocking, S ^c   Hutt, P B ^d   Lee, D ^e   Norwalk, L ^f   Salvatore, V ^g  

^a MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^b HEALTH SCIENCES AUTHORITY   (Singapore)

^c DAC Beachcroft LLP   (United Kingdom)

^d Department of International Practice   (United States)

^e HEALTH CANADA   (Canada)

^f Epstein Becker and Green's   (United States)

^g UNIVERSITY OF INSUBRIA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

PRESCRIPTION DRUG;

ACT; CANADA; CONFERENCE PAPER; DRUG LEGISLATION; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; LEARNING; LICENSING; MEDICAID; MEDICOLEGAL ASPECT; PRIORITY JOURNAL; REIMBURSEMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SINGAPORE; UNITED STATES; WORKSHOP; DRUG APPROVAL; LEGISLATION AND JURISPRUDENCE;

CANADA; DRUG APPROVAL; EUROPEAN UNION; LICENSURE; UNITED STATES;

EID: 84883167013     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.95     Document Type: Conference Paper

References (4)

1. Eichler, H-G. et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426-437 (2012).
2. US Food and Drug Administration. Federal Food Drug and Cosmetic Act, Section 356. Fast track products, (28 June 2012).
3. European Commission. Regulation No 1235/2010 of the European Parliament and of the Council: amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products, http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do? uri=OJ:L:2010:348:0001:0016:EN:PDF (15 December 2010; effective 2 July 2012).
4. Yeates, N., Lee, D.K. & Maher, M. Health Canada's progressive licensing framework. CMAJ 176, 1845-1847 (2007).