FDA Issues Guidance on Timeliness Disputes for Combination Products
The FDA has established a dispute resolution process for manufacturers to challenge the timeliness of premarket reviews for combination products.
Manufacturers can submit a timeliness dispute resolution request with the Office of Combination Products (OCP) in situations when the FDA does not review and act on a premarket submission within the applicable time frame, according to a recent guidance.
The applicable time frame will be determined by the type of premarket review goals to which the application is subjected. Combination products reviewed as drugs will fall under the review times established by the Prescription Drug User Fee Act, while products reviewed as devices will be subject to the review times contained in the Medical Device User Fee and Modernization Act. If a product is reviewed as both a drug and a device, the OCP will consider the time frames associated with each type of premarket application, the guidance states.
To view the guidance, "Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Products," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0182-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0182-gdl0002.pdf).
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