Comments on: Post-Approval Regulatory Priorities: Progress or Pile-Up? http://blog.pharmexec.com/2010/05/25/post-approval-regulatory-priorities/ The Business of Pharmaceuticals Wed, 08 Feb 2012 14:53:10 -0500 hourly 1 By: Ansis Helmanis http://blog.pharmexec.com/2010/05/25/post-approval-regulatory-priorities/comment-page-1/#comment-73748 Ansis Helmanis Thu, 27 May 2010 20:20:29 +0000 http://blog.pharmexec.com/?p=1636#comment-73748 Bill Your points are well taken. I would add as well a concern posed by the recent agreement between NICE and the MHRA, which will have NICE involved in pre-approval clinical trial development. A similar scenario is unfolding here in the US with the closer collaboration developing between FDA and CMS. Having the public rather than private sector defining the direction of new drug development is a trend worthy of notice. Ansis Bill

Your points are well taken. I would add as well a concern posed by the recent agreement between NICE and the MHRA, which will have NICE involved in pre-approval clinical trial development. A similar scenario is unfolding here in the US with the closer collaboration developing between FDA and CMS. Having the public rather than private sector defining the direction of new drug development is a trend worthy of notice.

Ansis

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