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Searching Content indexed under Food and Drugs Law by Elizabeth A. Robertson ordered by Published Date Descending.
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EMA Calls For Public Consultation On Clinical Trial Protocol
The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014).
European Union
4 Jul 2017
2
Guidance For European MA Holders To Prepare For Brexit
The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union.
European Union
4 Jul 2017
3
FDA Reorganizes ORA Staff
The FDA envisions that these changes will result in a high level of technical expertise and more uniform application of the ORA's policies and processes.
United States
4 Jul 2017
4
Senators Urge The Administration To Certify Imports Of Prescription Drugs From Canada
This letter follows a previous request from February 14, 2017, that the same senators made to Secretary Price.
United States
4 Jul 2017
5
EMA Green Lights New EudraVigilance System For Adverse Reactions
The new and improved version of the EudraVigilance database will be launched on November 22, 2017.
European Union
4 Jul 2017
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