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FDANonrulemakingFDA-2011-D-0602

Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; Availability

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Parenteral Drug Association filings
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Parenteral Drug Association filed 1 comment on this docket between Apr 16, 2012 and Apr 16, 2012. 0 other organizations filed here. The comment window closed 5216d ago.

What Parenteral Drug Association filed (1)

Apr 16, 2012· Parenteral Drug Association (PDA) - Comment· FDA-2011-D-0602-0011

On behalf of the Parenteral Drug Association (PDA), we are pleased to submit comments on the draft guidance for industry in the matter of "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product."

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Abstract

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