Trends in Combination Product Submissions and Requests
The number of combination products submitted for review in FY 2008 increased, reaching a 5-year high (see corresponding graph). The number of combination products submitted for review increased from 329 in FY 2007 to 330 in FY 2008, representing the second straight year of increases. An increase in application submissions for the review of combination products occurred for both CBER and CDRH in FY 2008 (from 40 to 54 and from 145 to 153, respectively) while CDER experienced a decrease (from 144 to 123).
Intercenter consult requests decreased in FY 2008 after three consecutive years (FY 2005 through FY 2007) of increases. The number of intercenter consultation requests on combination products decreased by 5 percent, from 390 in FY 2007 to 371 in FY 2008, but was higher than the requests in FY 2004 through FY 2006 (see corresponding graph). Since combination products involve components (biologics, drugs, and/or devices) that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they also raise challenging regulatory, policy, and review management issues. The differences in regulatory pathways for each component can impact the regulatory processes of all aspects of the product life cycle, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications. In addition, combination products increasingly use state-of-the-art, innovative technologies that challenge existing regulatory and scientific knowledge. More details about intercenter consultation requests are presented in the following sections.
The number of combination product assignment requests issued in FY 2008 decreased after two consecutive years (FY 2006 and FY 2007) of increases. The number of assignment requests issued decreased by 31 percent, from 32 in FY 2007 to 22 in FY 2008 (see corresponding graph). An increase occurred for assignment requests issued to CDER in FY 2008 (from 10 to 14) while assignment requests issued to CBER and CDRH decreased (from 3 to 2 and from 19 to 6, respectively). More details about assignment requests are presented in the following sections.
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