Profile

Hi Marline, Thanks very much for your response! I have sent an email to FDA's Office of Dietary Supplement Programs regarding the regulations and/or guidance for prescriptions supplements and I will post their response here if/when I receive it. Best regards, Brian ------------------------------ ...

Hi All, I have some questions about dietary supplement regulations and hope someone here might be able to help. FeRiva 21/7 is a prescription strength dietary supplement. FeRiva 21/7 The label is available on dailymed. FeRiva 21/7Rx OnlyDietary Supplement The carton has an NDC # 75854-318-28 ...

Hi Garima, Since your study is only being conducted in the US you do not need to produce a DSUR. You just need to submit an IND annual report to FDA. The DSUR is required by EU and other health authorities. FDA will accept a DSUR in lieu of an IND annual report but for a phase 1 study it's probably ...