US FDA issues Institutional Review Board (IRB) Written Procedures
Final Guidance for Institutions and IRBs effective May 2018
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New EMA Draft Guideline on Clinical Evaluation of Vaccines
Comments can be sent in until 30th October 2018
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USFDA’s Revision 1 of the Special Protocol Assessment Guidance
In Effect: April 2018 – May 2020
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Increasing oversight of API manufacturing through international collaboration
Report on the International API inspection program published
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New USFDA draft Guidance on in-vitro Diagnostics in Oncology Trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication
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