FDA Unveils Guidance for Biosimilar Development Today

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02/09/2012

FDA Unveils Guidance for Biosimilar Development Today

The FDA posted its draft guidance document for biosimilars on its website today. You can read a summary below outlined in the PharmTech Talk blog.

PharmTech Talk » It’s Here: FDA Unveils Guidance for Biosimilar Development.

Or you can go see the full document yourself on the Agency's site.

The FDA site notes that comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the availability of the draft guidance. Many comments are expected. Everyone - Have at It.

Posted by Bruce Lehr Feb 9th 2012.

Posted at 04:45 PM in Generics & Biosimilars, Regulatory Affairs & Policy | Permalink

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Some discussion of this from the Paten Doc blog
http://www.patentdocs.org/2012/02/fda-publishes-draft-guidelines-for-biosimilar-product-development-under-351k.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+PatentDocs+%28Patent+Docs%29&utm_content=Google+Reader

Posted by: bigredbruce | 02/10/2012 at 11:05 AM

Thanks to FDA for its course of action.

Posted by: Brochure Templates | 02/09/2012 at 11:40 PM

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