Activity

  • FDA recognize that timely Pre-market reviews also depends on the timely and effective review consultations and collaborations between and among centers. For this reason, the Agency has established a standard operating procedure for the the Inter center consultative/collaborative review process to help ensure the timeliness and consistency of inter center review. for example,consultation time frames are established taking into account the time frame of agency response to the regulatory submission. Furthermore, OCP actively monitors the progress of consultative reviews to ensure their timely and effective completion .

    https://www.fda.gov/RegulatoryInformation/Guidances/ucm126006.htm