Children Act

The FDA Modernisation Act of 1997 (FDAMA) included a number of elements that have increased the number of studies being performed on children. This was largely successful at increasing data on paediatric studies in the United States and has been now replaced by the Best Pharmaceuticals for Children Act, 4 January 2002 (Public Law No. 107-109). The European Commission has released (29 September 2004) proposed regulations that aim at promoting medicines for children which draw heavily on the successful FDA model. The regulations will probably be transposed into law in individual Member States in 2006. This means that all development plans will have to actively consider paediatric studies in the future. 

Best Pharmaceuticals for Children Act reauthorising these provisions, with changes, for another 5 years. The 2002 Act, like the 1997 provisions, relies upon incentives for voluntary industry testing of drugs used for children. 

Congress passes the Best Pharmaceuticals for Children Act, which encourages drug companies to carry out more studies on the benefits and side effects of drugs taken by children. 

Cooper KJ. Pediatric marketing exclusivity — as altered by the Best Pharmaceuticals for Children Act of 2002. Food Drug Faw J 2002 57 519h14. 

The FDA Modernization Act of 1997, the Best Pharmaceutical for Children Act 2002 and the Pediatric Research Act of 2003 have brought about improvements (see chapter on US Regulations). 

Primates with cingulate destruction will cease to groom or show acts of affection and may walk upon and over fellow monkeys as if they were part of the floor or an obstacle rather than a fellow being (MacLean, 1990 Joseph, 1996). Autistic children act as if other people are not present or are of no special interest (Fein et al., 1986) and move among other children as if among furniture (Kanner, 1943). 

The enactment by Congress of the Best Pharmaceuticals for Children Act (BPCA) (Food and Drug Administration, 2002) in 2002 led to the re-authorisation of the paediatric exclusivity incentive programme under the FDAMA. The BPCA not only renewed the exclusivity provision under the FDAMA, but also established an additional mechanism for obtaining paediatric drug information for off-patent... 

Food and Drug Administration (2002). Best Pharmaceuticals for Children Act. Public Law 107-109 (January 4, 2002). http //www.fda.gov/opacom/ laws/pharmkids/contents.html (accessed January 2006). 

Safety and protection (but not treatment) provision of secure accommodation under Section 25 of the Children Act 1989... 

The government paper Every Child Matters, which is now the basis for the Children Act 2004, aims to improve opportunities and outcomes for children, young people and families. This legislation is central to making inclusion happen in schools. Key elements include ... 

Children Act 2004 and Every Child Matters fact sheets www.dfes.gov.uk... 

Details of different agencies and their statutory remit and the function of the various agencies including schools under the Children Act, and a range of Every Child Matters initiatives, www.everychildmatters.gov.uk... 

The key focus will be on service provision and impact as a whole, rather than on the inspection of individual services. In the future some aspects of Extended School services may be inspeaed through joint Area Reviews. The Children Act 2004 requires local authorities to co-ordinate all the services provided by statutory, voluntary or private providers for children and young people aged 0-19 as part of an integrated children s service. The Framework for the Inspection of Children s Services sets out the principles to be applied in all relevant inspections of services for children and young people. Guidance for these is found in three main documents published by OFSTED (2005) ... 

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