Monday, December 22, 2008

FDA - FAQs About Combination Products

If you're just getting into the regulations that govern combination products, or need a quick refresher, then check out this collection of FDA Frequently Asked Questions about combination products, published by the FDA. Here's a quick list of what you'll find . . .

What is a combination product?
What are some examples of combination products?
What are the roles of the Office of Combination Products?
What staff members comprise the Office of Combination Products, and who can I contact for specific issues?
I have some questions about how a combination product will be regulated. What information will help OCP understand my product so they may respond to my inquiry?
How can I contact OCP?
Where can I find out about workshops and public meetings on combination products?
How can I get copies of slides from OCP presentations?
What has OCP accomplished so far, and what is the Office currently working on?
Product Jurisdiction/Assignment of Combination and Non-Combination Products
How are combination products assigned for review?
How do I determine which Center will review my combination or non-combination product?
How do I submit a Request for Designation for a combination or non-combination product?
How promptly will my RFD be reviewed?
Premarket Review and Postmarket Regulation of Combination Products
What investigational application should I use for a combination product?
What types of marketing applications are required for a combination product?
Does OCP review marketing applications for combination products?
What format should I use to submit a marketing application for a combination product?
What is the difference between consultative and collaborative reviews of combination products?
How do I request that OCP or review staff from a consulting Center attend a regulatory meeting, such as a pre-IDE or pre-IND meeting, with agency reviewers?
What good manufacturing practice regulations apply to combination products?
How are adverse events reported for combination products?
Where can I get information about user fees for combination products?
Where can I find guidance for what kind of safety and effectiveness information is needed to support approval of a combination product?
Where can I find guidance for how master files can be used in the submission of information relevant to my combination product?
We have developed a new combination product and would like to initiate a dialogue with the appropriate FDA staff to obtain guidance on how to go about obtaining approval. However, we have limited experience in dealing with the FDA and do not know whom we should contact. Can the Office of Combination Products help?
How do I submit a formal request that OCP resolve a dispute regarding the timeliness of premarket review of a combination product?
The Medical Device User Fee and Modernization Act (MDUFMA) requires FDA to report annually on the numbers and types of combination products reviewed, and the timeliness of such reviews. Where can I find these data, and how does FDA determine the types of combination products?
Other Issues
How are products that combine two or more drugs regulated?
How are products that combine a drug and a cosmetic regulated?
How are products that combine a drug and a dietary supplement regulated?
Where can I find information about novel drug delivery systems?
Where can I find information about in vitro diagnostic tests used in pharmacogenomics?
I believe my combination product may qualify for designation as an orphan drug or biological product, or as a humanitarian use device. Where can I find information about orphan product regulation?
Where can I find more information about the regulation of nanotechnology products, including combination products involving nanotechnology?

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