FDA issues final guidance user fees for combination products

The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the different programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Amendments (MDUFA) programs.

The update replaces a final guidance issued in April 2005 to make it more consistent with current user fee programs and to reflect combination product provisions in section 503(g) of the Federal Food and Drug Cosmetic Act (FD&C Act).

The question-and-answer guidance includes background information on combination products, how the agency determines user fees for single applications and two applications, and information on requesting user fee waivers or reductions of user fees.

FDA states that a combination product is assigned to an agency center that will have primary jurisdiction for its premarket review and regulation. “Under section 503(g)(1) of the FD&C Act (21 U.S.C. 353(g)(1)), the assignment to a lead center is based upon a determination of the primary mode of action (PMOA) of the combination product. For example, if the PMOA of a combination product is that of a biological product, then the combination product would be assigned to the Agency center responsible for premarket review of that biological product.”

FDA said combination products may be reviewed in a single application or in separate applications for its constituent parts.

For most combination products, one application is appropriate, yet noted there are circumstances in which an applicant may choose to submit two applications. In these situations, “the applications may fall under the same or different user fee programs. In such cases, FDA would evaluate each application user fee independently under the relevant user fee statute, as if it were a stand-alone application, and two application fees would be assessed (i.e., one fee for each application).”

In situations where applicants must file MDUFA and PDUFA applications, FDA may grant some user fee relief to sponsors. For these applicants, FDA will waive the PDUFA fee if the product protects the public health, and the sponsor has limited resources.

The agency will also waive the PDUFA user fee for innovative products for applicants that have limited resources. Eligible product must demonstrate “new, progressive methods and forward-thinking in the treatment or diagnosis of disease or is at the forefront of new medical technology” and “there are no comparable alternatives for treatment, prevention, or diagnosis available in the U.S. market.”

Besides these waiver programs, other PDUFA waiver programs include the small business waiver, the exception for orphan designated products, and the state or federal government entity exemption.

Under MDUFA, waiver programs include the humanitarian device exemption (HDE) program and the pediatric conditions of use program if the proposed condition for use is solely for the pediatric populations.

This guidance should be used in conjunction with the guidance for industry Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products and the appropriate MDUFA guidance documents.

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FDA issues final guidance user fees for combination products

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