Intercenter Agreements
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MDUFMA added Section 503(g)(4) to the Act; requires FDA to review each agreement, guidance, or practice specific to the assignment of combination products to agency centers and determine whether the agreement, guidance or practice is consistent with the requirements of Section 503(g) of the Act.
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Jurisdictional Update issued in September 2005.
http://www.fda.gov/oc/combination/intercenterupdate.html
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FDA plans to issue Federal Register notice seeking stakeholder comment on agency's review of agreements, guidance and practices.