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Re: Legal development: FDA's discretion to declare a product candidate a drug vs a device is limited CRMD initially attempted to file Neutrolin as a device but was rejected by the FDA. Seems unlikely the outcome would be different now which imo is in CRMDs best interest since they are close to a approval as a drug, a staus that could improve pricing and patent protection and longevity. |
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Msg # | Subject | Author | Recs | Date Posted |
37349 | Re: Legal development: FDA's discretion to declare a product candidate a drug vs a device is limited | rmgillis | 16 | 12/9/2019 5:09:01 PM |