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Thank you Glen for your input, this is useful.  Hi Olesya, For this specific case, this is an Orphan drug so they are exempt from PSP requirements. Also, they already included some pediatric groups in their ongoing studies. They are mostly interested in the pediatric incentives, but I agree with ...

Dear all, I am doing some research around Written Request for voluntary pediatric studies. I understand that a sponsor can request a Proposed Pediatric Study Request (PPSR) in order to have a Written Request issued by the FDA. As the incentive is pediatric exclusivity, there is no real rush to do ...

Hi all, The FDA is asking us the US address where the sponsor is conducting pharmacovigilance activities and handling ADEs for one approved product under an NDA.  I do not see any clear requirements about having specifically someone in the US for post-marketing PV activities. The sponsor is doing ...

Hi all, I know that there is a collaboration between FDA and Department of Defense (DoD) to accelerate the development of medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. The DoD has a Priority List in place with ...

Hello, The only IND submissions for which there is a formal response/review time for FDA is for a new IND (30 days), or for FTD/BTD/RMAT/SPA (60 days).  It is undefined for all other IND amendments including CMC amendments, NC & C info amendments, etc.  In most cases there is no need to follow up ...