FDA Seeks Comment on Revised Application Review Program

On July 6, FDA requested feedback on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program; see II.B). The Program is part of the performance commitments FDA agreed to under the Prescription Drug User Fee Act (PDUFA) legislation signed into law July 9 (P.L. 112-144). Of interest to pharmacy, the Program would provide opportunities for increased communication and transparency by building in midcycle communications and late-cycle meetings between FDA and manufacturers who submitted applications. APhA supports such activity as it aims to improve the drug review process...(especially, if a risk evaluation and mitigation strategy (REMS) program is being considered).

Comments are due on August 6, 2012.

July 11, 2012