Food & Drug Administration (FDA)

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[1][2][3][4]

Notes

  • a medical ethicist suggests the FDA simplify its policies to state 'We are not taking anybody with any kind of conflict on an advisory committee.'[2]

Additional terms

References

  1. ↑ Sacks LV et al Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012. JAMA. 2014;311(4):378-384. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24449316 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1817795
    Downing NS et al Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA. 2014;311(4):368-377. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24449315 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1817794
    Rome BN et al FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012. JAMA. 2014;311(4):385-391. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24449317 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1817796
    Goodman SN and Redberg RF Opening the FDA Black Box. JAMA. 2014;311(4):361-363. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24449313 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1817770
  2. ↑ 2.0 2.1 Piller C, You J Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns. Science. July 6, 2018. Vol 361, Issue 6397 http://www.sciencemag.org/news/2018/07/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical
  3. ↑ U.S. Food & Drug Administration (FDA) Human Drug Advisory Committees https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/default.htm
  4. ↑ http://www.fda.gov (800) FDA-1088
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