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Hi Olga, Prepare a risk assessment report. If your product meets USP Option 1 or 2 and that you are not adding solvents to your product, the test is not required. Best Regards, ------------------------------ Tyng-Yi (Tina) Lee MS RAC Consultant North Brunswick NJ United States of America ...

Usually just 25/60. Check your stability commitment and post approval protocol in 3.2.P.8.2. In the commitment, you probably have different conditions for PV batch, Annual batch and Supplements. Best Regards, ------------------------------ Tyng-Yi (Tina) Lee MS RAC Consultant North Brunswick ...

Hi David, RLD is not a must for 505(b)(2).  You can reference safety and efficacy info from published literatures and approved products. Best Regards, ------------------------------ Tyng-Yi (Tina) Lee MS RAC Consultant North Brunswick NJ United States of America ----------------------- ...

​Dear Sabrina, There are no fees for DMFs used to exclusively support NDA or INDs.  Please clink the link below and search "FEES" Drug Master Files (DMFs) https://www.fda.gov:80/FDAgov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm Best Regards, ...