Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study

Author:

Hwang Thomas J.,Tomasi Paolo A.ORCID,Bourgeois Florence T.ORCID

Funder

Burroughs Wellcome Fund

Publisher

Public Library of Science (PLoS)

Subject

General Medicine

Reference26 articles.

1. Study on off-label use of medicinal products in the European Union;M Weda,2017

2. A prospective questionnaire assessment of attitudes and experiences of off label prescribing among hospital based paediatricians;JS McLay;Arch Dis Child,2006

3. Paroxetine,2018

4. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union. L 378/1. 2006 Dec 27.

5. Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. Official Journal of the European Union. L 378/20. 2006 Dec 27.

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