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Searching Content indexed under Food and Drugs Law by Indradeep Bhattacharya ordered by Published Date Descending.
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Date
1
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
6
French ANSM Clarifies Guidance Related To Raw Materials For Pharmaceutical Use
Facilities located in France where RMPU is stored on behalf of distribution companies also fall within the scope of the authorization/declaration requirement.
France
15 May 2017
7
EMA Adopts A Guidance Concerning Periodic Safety Update Reports
The Explanatory Note addresses issues encountered by marketing authorization holders, and the Q&A is intended to help assessors evaluate PSURs in a consistent way.
European Union
15 May 2017
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