Institute for Safe Medication Practices - Comment

Document ID: FDA-2012-N-1248-0030
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: February 28 2013, at 12:00 AM Eastern Standard Time
Date Posted: March 20 2013, at 12:00 AM Eastern Standard Time
Comment Start Date: January 14 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: March 1 2013, at 11:59 PM Eastern Standard Time
Tracking Number: 1jx-83xu-8rp2
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This is comment on Notice

Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing

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See attached file(s) The file below contains the full comments of the Institute for Safe Medication Practices. Abstract This proposal could compromise patient safety, is unnecessary given seven existing expedited approval programs, has no clear public health justification for exposing patients to increased risks, and is insufficiently researched and documented to permit a clear evaluation.

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Institute for Safe Medication Practices ISMP Comment on Alternative Approval Pathway

Title:
Institute for Safe Medication Practices ISMP Comment on Alternative Approval Pathway

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Amicus Therapeutics, Inc - Comment
Public Submission Posted: 03/20/2013 ID: FDA-2012-N-1248-0036