Expanded Access Programme: looking for a common definition

Author:

Iudicello Antonella,Alberghini Lucia,Benini Giulia,Mosconi Paola

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Reference25 articles.

1. 21 CFR Parts 312 and 316: Expanded Access to Investigational Drugs for Treatment Use. (Docket No. FDA–2006–N–0238, formerly Docket No. 2006N–0062. Federal Register/Vol. 74, No. 155/ 13 August 2009/Rules and Regulations, revised as of 1 April 2013).

2. Questions and answers on the compassionate use of medicines in the European Union. 21 January 2010. Doc. Ref: EMEA/72144/2006 (rev).

3. Chin R, Lee BY. Study groups. Principles and practice of clinical trials medicine. 2008;5:91.

4. Taylor GJ, Wainwright P. Open label extension studies: research or marketing? BMJ. 2005;331:572–4.

5. Guideline on compassionate use of medicinal products, pursuant to article 83 of regulation (EC) No. 726/2004. London 19 July 2007. Doc. Ref: EMEA/27170/2006.

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