Abstract
The lack of specific drugs and labelling recommendations for the paediatric population is a longstanding problem. Physicians frequently prescribe marketed medicines as off-label on the basis of clinical practice and medical knowledge. Moreover ‘unapproved’ drugs are employed in different formulations, routes, combinations to adapt them to children. TEDDY studied the definitions of off-label and unlicensed use of medicines in paediatrics as defined by regulatory agencies and by scientific literature. This study confirmed the need for a common definition for unlicensed and off-label uses to be incorporated into the European legislation. On the basis of the results of this investigation, TEDDY conducted a survey in order to reach a common definition with the intention to favour the use of a European official regulatory terminology and facilitate pharmaco-epidemiological research. The definitions will be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
