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PUBLICATIONS / NUMBER 130

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Jan 2017

Jan 2017

SAFETY OBSERVER N130

16 PAGES

  • FDA issues final rule on Safety Reporting for Combination Products

  • EMA issues adopted guideline on Post-Authorisation Efficacy Studies

  • EMA issues revised guidance on Signal Detection methods in EudraVigilance

  •  Czech Republic and Australia revise Clinical Trials Safety Reporting rules

  • ANSM initiates suspension of Uvesterol D as a precautionary safety measure

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