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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdChildren/paediatrics
The following articles on this topic have been published in
CRAdvisor (CRA) – the year, issue number
and starting page number for each are listed below:
Back to index |
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2007 |
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CRA 2007; 183:1 |
Peadiatric Regulation adopted. |
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CRA 2007; 184:2 |
EU Paediatric Regulation 1901/2006 now in force. |
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CRA 2007; 187:2 |
European Commission issues guidelines for paediatric investigation plans. |
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CRA 2007; 187:8 |
Initiative to reduce development costs. |
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CRA 2007; 190:8 |
Paediatric study costs on the up. |
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CRA 2007; 193:6 |
EMEA guideline on trials in small populations. |
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CRA 2007; 194:8 |
Templates for the EU Paediatric Regulation. |
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CRA 2007; 195:8 |
EMEA Paediatric Working Party meets for last time. |
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2006 |
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CRA 2006; 163:1 |
EC adopts modified proposal for a regulation on medicines for children. |
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CRA 2006; 164:2 |
Modifications to proposed EC paediatric regulations. |
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CRA 2006; 169:8 |
Common position reached on the paediatric regulation. |
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CRA 2006; 171:8 |
Parents and paediatric research. |
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CRA 2006; 173:2 |
FDA issues draft guidance on US trials involving children as subjects. |
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CRA 2006; 176:12 |
EMEA final guideline on pharmacovigilance in children. |
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CRA 2006; 177:6 |
EMEA finalises guideline on pharmacovigilance for medicines used by
children. |
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CRA 2006; 179:1 |
Implementation of the Paediatric Regulation. |
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CRA 2006; 179:2 |
New guideline on the ethics of clinical trials in children. |
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CRA 2006; 179:5 |
A positive approach to paediatric informed consent. |
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CRA 2006; 182:2 |
Revised ethics guidance for trials in children. |
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2005 |
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CRA 2005; 143:1 |
Increase in paediatric research in USA and Europe predicted for 2005. |
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CRA 2005; 143:3 |
Conference on children's medicines. |
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CRA 2005; 154:4 |
EC consultation on regulation of paediatric medicines. |
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CRA 2005; 156:3 |
Centre accused of violating children's rights in AIDS research trials. |
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CRA 2005; 156:4 |
Special HHS protections for children in research. |
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CRA 2005; 157:6 |
EMEA drafts guideline for pharmacovigilance in children. |
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CRA 2005; 158:1 |
EMEA consults on draft guideline for pharmacovigilance in children. |
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CRA 2005; 158:8 |
Paediatric research. |
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CRA 2005; 159:1 |
Industry concerns over EMEA proposals for paediatric medicines regulation. |
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CRA 2005; 159:2 |
FDA issues draft guidance on complying with the Pediatric Research Equity
Act. |
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CRA 2005; 161:2 |
Conflicts of interest for National Cancer Institute Pediatric Central IRB
members. |
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CRA 2005; 162:4 |
Report from EFGCP Working Party on children's medicines. |
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CRA 2005; 162:8 |
Help for studies in children. |
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2004 |
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CRA 2004; 128:6 |
Draft EU regulation on medicinal products for paediatric use. |
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CRA 2004; 129:3 |
EC proposes regulation to increase products approved for paediatric use. |
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CRA 2004; 129:4 |
Commission proposal on medicines for paediatric use: rationale and
overview. |
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CRA 2004; 130:6 |
FDA supports more access to information. |
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CRA 2004; 132:3 |
Paediatric trials on the way. |
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CRA 2004; 140:2 |
EC proposes regulation on paediatric medicines. |
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CRA 2004; 141:1 |
EU regulation proposed for promoting medicines for children. |
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CRA 2004; 141:7 |
Parental willingness in paediatric recruitment. |
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2003 |
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CRA 2003: 102:2 |
Mandatory paediatric testing in the USA? |
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CRA 2003; 102:6 |
New combination vaccine protects against five childhood diseases. |
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CRA 2003: 103:5 |
Paediatric clinical trials present new challenges. |
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CRA 2003; 110:5 |
EMEA focuses on extremes of age. |
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CRA 2003; 112:6 |
What motivates subjects to enter paediatric trials? |
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CRA 2003; 114:6 |
FDA discusses paediatric drug safety under Best Pharmaceuticals for
Children Act. |
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CRA 2003; 114:7 |
Paediatric expert to sit on CDRH panel. |
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CRA 2003; 116:6 |
FDA draft guidance on pre-market assessment of paediatric medical
devices. |
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CRA 2003; 116:7 |
Pediatric Research Equity Act approved. |
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CRA 2003; 116:8 |
FDA presents paediatric drug safety report. |
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CRA 2003; 117:6 |
US Senate approves Pediatric Rule. |
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CRA 2003; 122:7 |
Will you help seriously ill children to enjoy their last few months? |
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2002 |
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CRA 2002; 86:6 |
Better medicines for children. |
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CRA 2002; 89:1 |
HHS will enforce 'drugs for children' rule. |
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CRA 2002; 89:2 |
EU propose legalisation of obligatory paediatric trials. |
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CRA 2002; 99:7 |
Paediatric protection under scrutiny. |
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CRA 2002; 100:12 |
Overview of documents produced by the ICH process. |
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CRA 2002; 101:6 |
Design of orphan drugs trials in children. |
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2001 |
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CRA 2001; 60:6 |
Latest on paediatric studies. |
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CRA 2001; 63:1 |
Horrific extent of organ research revealed. |
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CRA 2001; 66:4 |
Guidance for paediatric trials. |
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CRA 2001; 69:1 |
FDA releases interim rule for paediatric trials. |
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CRA 2001; 72:2 |
New requirements for IRB review of paediatric trials. |
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CRA 2001; 74:6 |
FDA urged to waive parental consent for minors. |
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CRA 2001; 76:6 |
A European conference on clinical research in children. |
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CRA 2001; 77:3 |
FDA Drug Centre establishes new office. |
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2000 |
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CRA 2000; 40:6 |
Doctor forced to take child organs! |
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CRA 2000; 59:6 |
Paediatric trials are to be encouraged in the EU. |
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1999 |
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CRA 1999; 29:4 |
Declaration of Ottawa protects children. |
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CRA 1999; 31:4 |
Patient information sheets for children. |
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CRA 1999; 34:6 |
ADR reporting in children. |
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CRA 1999; 39:3 |
New guidelines for studies in children. |