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Hi Kathleen -  here's some info that may be helpful.  Today, there are no PDUFA fees associated with submission of clinical data for a PAS. That fee for supplements (of any kind) was eliminated and replaced under PDUFA VI authorization with a "Program Fee" for greater predictability in fees to be received ...

Hello - you can find that list here https://www.fda.gov/media/101440/download.  It is a link that's available on FDA's PREA page here https://www.fda.gov/drugs/development-resources/pediatric-research-equity-act-prea hope that helps. ​ ------------------------------ Kimberly Belsky Head of Regulatory ...

​Hello Shivam - Regarding you query, you may be interested in a recently published article based on a 2019 RAPS Convergence Session Estimating the Probability of Regulatory Registration Success Posted 13 February 2020 | By Jennifer R. Weidman, PhD and Kimberly Belsky, MS  Estimating the Probability of ...

Hello Heather - to follow onto David's comment, also refer FDA's Guidance on the Physician Labeling Rule and the table on page 29 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075082.pdf ------------------------------ Kimberly Belsky Executive Director, ...

RAPS members: Get ready! There are even more great happenings coming you way! What an amazing and energizing two days. Thank you to the RAPS staff for leading this effort. ------------------------------ Kimberly Belsky Executive Director, AdPromo Califon NJ United States