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Kuros Biosurgery AG - Comment

Document ID: FDA-2011-D-0597-0018
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: November 23 2011, at 12:00 AM Eastern Standard Time
Date Posted: December 5 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: August 29 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: November 28 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80f71cd5
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Dear Sir or Madam, Kuros Biosurgery AG very much welcomes the fact that FDA has issued this draft guidance for consultation. Kuros Biosurgery AG is hereby providing its comments to the Draft Guidance “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” following its release for public consultation in August 2011. Please do not hesitate to contact us if you have any question. Sincerely, Nancy Falla, PhD Head of Regulatory Affairs Kuros Biosurgery AG Phone: +41 44 200 56 00 Fax: +41 44 200 57 13

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Kuros Biosurgery AG - Comment

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