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Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]
The Modified Checklist for Autism in Toddlers (M-CHAT) is a psychological questionnaire that evaluates risk for autism spectrum disorder in children ages 16–30 months. The 20-question test is filled out by the parent, and a follow-up portion is available for children who are classified as medium- to high-risk for autism spectrum disorder.
The Checklist for Autism in Toddlers (CHAT) is a psychological questionnaire designed to evaluate risk for autism spectrum disorder in children ages 18–24 months. The 14-question test is filled out by the parent and a pediatrician or physician and takes approximately 5 minutes to complete. [ 1 ]
Screening tools include the Modified Checklist for Autism in Toddlers (M-CHAT), the Early Screening of Autistic Traits Questionnaire, and the First Year Inventory; initial data on M-CHAT and its predecessor, the Checklist for Autism in Toddlers (CHAT), on children aged 18–30 months suggests that it is best used in a clinical setting and that ...
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
The Autism Treatment Evaluation Scale (ATEC) is a 77-item diagnostic assessment tool that was developed by Bernard Rimland and Stephen Edelson at the Autism Research Institute. The ATEC was originally designed to evaluate the effectiveness of autism treatments, but it may also be beneficial as a screening tool for children.