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Capitol Connections Article FDA Guidelines 1.10.14
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Member Action Item: Comments for FDA's Draft Guidance Documents (CPGs) Due by February 4th!

The US Food and Drug Administration (FDA) last month released its draft guidance documents (CPGs) for the new 503(b) and 503(a) sections of the Drug Quality and Security Act. 

Click here to review 503(b) section (Discusses how registration will be handled)

Click here to review 503(a) section (Please note page 5 and start at line 155) 

Both of these documents are open for comment and input to the FDA by February 4, 2014. IACP currently is reviewing and will be compiling our formal submission to the FDA.

ACTION ITEM: IACP strongly encourages all members to review these documents and submit comments on how these drafts may affect your business and your practice. Additionally, you should circulate these to physicians and other prescribers with whom you work so that they are informed of the pending changes as well. The electronic address for submitting comments to the FDA is including in each of the 503(b) and 503(a) documents.

Please email IACP with any questions or CPG input at


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