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10.1186/s13023-016-0393-3 http://scihub22266oqcxt.onion/10.1186/s13023-016-0393-3 C4778287!4778287!26939863     free     free     free Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Orphanet+J+Rare+Dis 2016 ; 11 (ä): ä Nephropedia Template TP {{tp|p=26939863|t=2016. Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive?|pdf=|usr=}}{{26939863}} gab.com Text Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive JO: Orphanet J Rare Dis http://www.kidney.de/pget.php?&tw=1&pmid=26939863 #FOAvip Background: Regulatory and economic frameworks stimulated the research and development of orphan drugs, but very little has been done for devices necessary for the in-vivo diagnosis, prevention and treatment of life-threatening conditions with a low prevalence/incidence. Discussion: A general public consultation in Europe has shown a positive attitude towards an ?orphan device? directive. The United States of America have a Humanitarian Use Device exemption, but Europe is still waiting for such a stimulating framework. Post-marketing surveillance (?materio-vigilance?) will be necessary for follow-up, patient-reported outcome measures (quality of life versus survival) needed and off-label use data available for patient-safety reasons. Summary: The marketing period for devices is shorter than for medicinal products. Incentives are necessary to stimulate research and development of such ?orphan devices? especially when surgical intervention is the only option. Twit Text FOAVip Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive ????Orphanet J Rare Dis http://www.kidney.de/pget.php?&tw=1&pmid=26939863 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26939863 #FOAvip English Wikipedia <ref>{{Cite pmid|26939863}}</ref> Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive? #MMPMID26939863 Dooms MM Orphanet J Rare Dis 2016[]; 11 (ä): ä PMID26939863show ga Background: Regulatory and economic frameworks stimulated the research and development of orphan drugs, but very little has been done for devices necessary for the in-vivo diagnosis, prevention and treatment of life-threatening conditions with a low prevalence/incidence. Discussion: A general public consultation in Europe has shown a positive attitude towards an ?orphan device? directive. The United States of America have a Humanitarian Use Device exemption, but Europe is still waiting for such a stimulating framework. Post-marketing surveillance (?materio-vigilance?) will be necessary for follow-up, patient-reported outcome measures (quality of life versus survival) needed and off-label use data available for patient-safety reasons. Summary: The marketing period for devices is shorter than for medicinal products. Incentives are necessary to stimulate research and development of such ?orphan devices? especially when surgical intervention is the only option. äOrphan devices: yesterday is history; tomorrow is mystery: towards a E(epmc).pdf DeepDyve Pubget Overpricing