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sorry couldnt find an answer did however find this on the fda...

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    sorry couldnt find an answer did however find this on the fda  site which may be relevant




    How promptly will my RFD be reviewed?

    The Office of Combination Products (OCP) will make its jurisdictional determination within 60 days of filing the RFD, as required by 21 CFR 3.8 and Section 563 of the Food, Drug and Cosmetic Act. OCP’s review performance for RFDs are available on the Combination Products section of the FDA website.

    Premarket Review and Postmarket Regulation of Combination Products

    What investigational application should I use for a combination product?

    a. How many applications?

    FDA only needs one investigational application for a combination product.  That application should include all information on the entire combination product.  For example, if the investigation is for a drug-device combination product, the application should include the details on the drug and device that typically would be submitted in an IND and IDE, respectively.

    b. How to decide if an IND / IDE may be needed?

    FDA considers the entire combination product in determining the need for an investigational application.  For example, in some investigational protocols one part of the combination product might be already approved but another part is new and raises safety risks.  Therefore, the entire combination product raises a safety risk and would be under an investigational application.

    In some instances both the drug and device are already approved for different indications, but when the two are used together a new risk exists.  In such cases, the combination product as a whole would be under an investigational application submitted to the lead center.
 
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