Ethics/Regulatory

India to revise drugs and cosmetics bill

Tuesday, June 28, 2016

The Union Cabinet, chaired by the Prime Minister Shri Narendra Modi, has decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which had been introduced in the Rajya Sabha in August of 2013. The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill. 

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EMA, FDA reinforce collaboration on patient engagement

Tuesday, June 28, 2016

The EMA and the FDA have set up a new ‘cluster’ on patient engagement. The cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorization activities related to medicines.

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Ombudsman calls for more transparency

Tuesday, June 14, 2016

The European Ombudsman, Emily O’Reilly, has welcomed increased transparency in the clinical testing of Humira, one of the world’s biggest selling drugs, following her inquiry into the publication of clinical study reports.

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Senate approves brain cancer research Bill

Tuesday, May 31, 2016

The Senate Committee on Appropriations has approved legislation that provides for the inclusion of “brain cancer” among the disorders eligible for study by the Department of Defense‘s (DoD) Peer Reviewed Cancer Research Program (PRCRP). This provision was included in the fiscal year 2017 Defense Appropriations Act, and mirrors action taken by the House on May 11 to add brain cancer to the PRCRP in its version of the Defense Appropriations Act.

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