Navigating the new FDA world of Combination Products (FDA Compliance Train)
Venue: Online Event
|Event Date/Time: Jun 22, 2011||End Date/Time: Jan 22, 2011|
Itâ€™s no longer just the â€œdrug-eluting stentâ€ that the FDA sees as a combination product, but also the drug being delivered in a pre-loaded syringe, or by a programmable pump. Drug-device interactions need to be specifically tested and the specific compatibility/stability test result information listed in the label.
FDA has increased their level of scrutiny and is adding approval steps for these â€œcombinationâ€ products even when the drug and device/s are made by competing companies. What if company a (device) does not want to work with company b (drug) and yet their products are used together (i.e. in â€œcombinationâ€)? Drug and device companies need to be prepared for the added work.
Who is responsible for the testing and why would both companies need to do all the same testing? What additional risk is associated with a combination product? Reporting of adverse events is another complex area. Is it the drug or device that needs to be reported? These are all new questions which need to be addressed since two non-collaborating entities may be involved in bringing a combination product to market.
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