Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety

Author:

Cuzzolin Laura,Atzei Alessandra,Fanos Vassilios

Publisher

Informa Healthcare

Subject

Pharmacology (medical),General Medicine

Reference80 articles.

1. Research in children

2. Clinical trials of medication in children, 1996–2002

3. FOOD AND DRUG ADMINISTRATION: Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Department of Health and Human Services, Food and Drug Administration. Federal Register, December (1998) 63(231):66632-66672.

4. NO AUTHORS LISTED: Best Pharmaceuticals for Children Act. Pub. L. 107th Congr. (2002):107-109.

5. CPMP/ICH: Note for guidance on clinical investigation of medicinal products in the paediatric population. Eudralex CPMP/ICH/2711/99 – adopted July (2000).

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