Recently the Office of Combination Products published a list of ”Frequently Asked Questions (FAQ)” that are often asked of the Office. This list of approximately twenty eight questions include several questions with rather obvious answers as well as questions that include where to obtain additional information regarding annual reports.
The list includes the roles of the “Office” and its staff members. My personal experience is that these staff members are easy to contact and one should not hesitate to contact them if you have any questions. Patricia Love, MD, Deputy Director, will always respond in a timely fashion. Her phone number is 301/796-8930.
There exists a section entitled “Product Jurisdiction/Assignment of Combination and Non-Combination Products” which discusses how combination products are assigned for review. It also discusses which Center will review your combination or non-combination product. The Request For Designation (RFD) process is outlined in 21 CFR Part 3.
To determine what investigational application should be used for a combination product, you may want to review the sections that discusses “How many applications”, and also to decide if an IND/Ide may be required. You can also learn which center has the lead.
Types of marketing applications that may be required is explained as well as whether OCP reviews marketing applications. It doesn’t, the appropriate center does.
A variety of miscellaneous questions include 1) what GMPs apply to combination products, 2) how are adverse events reported, 3) how about user fees, 4) the requirements for safety and effectiveness information, 5) guidance on master files relative to the submission of information, etc.
To view the entire document, please visit the FDA web site at: (Click Here)
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