Pharmaceutical Regulatory Affairs: Open Access

Department of Urology, Pediatric Urology and Andrology, Ludwig-Maximilians-University, 35392 Giessen, Germany

Publications

• Mini Review   
  Phase 0 Trials and FDA and EMEA Standards′ Impact on Drug Development
  Author(s): Kurt Naber*
  
  Guidelines for the design of pivotal psychiatric drug trials used in new drug applications are produced by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Who is involved in the development of the guideline and what specific trial design recommendations they provide are unknown. A cross-sectional investigation of the FDA Guidance Documents and the EMA Clinical Efficacy and Safety Guidelines. Results of the study: 1) declared conflicts of interest among members of the guideline committee; 2) the creation of guidelines and the arrangement of the commenting phases; 3) categorisation of partners who remark on draft and last rules as per irreconcilable circumstances ('industry', 'notindustry however with industry-related clashes', 'autonomous', 'indistinct'); and (4) recommendations for the trial design... Read More»
  DOI: 10.37421/2167-7689.2022.11.340

  Abstract HTML PDF