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FDANonrulemakingFDA-2011-D-0605

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

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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. 1 other organizations filed here. The comment window closed 189d ago.

What Parenteral Drug Association filed (1)

Apr 16, 2012· Parenteral Drug Association (PDA) - Comment· FDA-2011-D-0605-0010

On behalf of the Parenteral Drug Association (PDA), we are pleased to submit comments on FDA's Draft Guidance in the matter of "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product".

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Abstract

No abstract recorded.

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Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (FDA) — Parenteral Drug Association | OpenPolis