OR WAIT null SECS
© 2024 MJH Life Sciences™ and BioPharm International. All rights reserved.
Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which type of application process is appropriate.
An FDA guidance document finalized on July 16, 2024 instructs staff members as well as the drug industry at large about the applicable user fees for applications for combination products, as defined under the Code of Federal Regulations (CFR), Title 21, Part 3.2(e) (1,2). Specifically, the guidance dictates that if a single application is submitted for a combination product, the user fee associated with that type of application should be assessed. It also outlines the process by which combination products are assigned for review.
A combination product, according to the CFR, is characterized by any of four criteria:
Drug–drug, device–device, and products containing only multiple biologics do not meet the definition of a combination product under these terms (1).
FDA precedent states that combination products may be reviewed in a single application or in separate applications for each constituent part, both of which are scenarios reviewed in the new guidance (1). If an applicant decides to submit two applications for a cross-labeled product, each application would be assessed its own particular user fee.
FDA may determine that a single application is not appropriate for a certain combination product, and that separate applications are warranted. In that case, which FDA said in the guidance document is rare, the total amount of the application fee could be reduced if the applicant qualifies for waiver provisions under the Prescription Drug User Fee Act (PDUFA) of the Federal Food, Drug, and Cosmetic Act (1). Provisions of this guidance do not apply to PDUFA prescription drug program fees.
The guidance document contains information on how to request a fee reduction or waiver under the PDUFA provisions and also how to do the same as a small business, pursuant to medical device user fee amendment guidelines.
The guidance was jointly issued by FDA’s Office of the Commissioner, Office of Clinical Policy and Programs, and Office of Combination Products and replaces a previous final guidance for industry from April 2005.
1. FDA, Guidance for Industry and FDA Staff, Application User Fees for Combination Products (OCP, July 2024).
2. CFR Title 21, Part 3.2(e) (Government Printing Office, Washington, DC) 173. ecfr.gov/current/title-21/chapter-I/subchapter-A/part-3/subpart-A/section-3.2