FDA’s Center for Drug Evaluation and Research plans to publish 50 new or revised draft guidances in calendar year 2012. The agency recently posted the current list of forthcoming guidances on its website. CDER ticked off three major items on the list when it issued draft biosimilars guidances last month Also see "FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics" - Pink Sheet, 13 February, 2012.. The agency plans to issue one more biosimilars guidance this year. Below are some of the key documents in the works, which were not included in the annual guidance agenda FDA published in a December Federal Register notice Also see "FDA’s Guidance Document To-Do List" - Pink Sheet, 3 January, 2011..
FDA’s Guidance Document To-Do List Grows
Since releasing its annual guidance agenda in December, FDA has added a number of guidances to its development agenda.
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