FDA prioritising….16 Feb 2022 07:20
I also follow HEMO who have just released an RNS to inform of FDA reply to delay of pre implementation meeting for a new drug they are developing ( very good work!) but took from it the reason given by FDA as As noted above, the process for pre-IND meetings has been amended by the FDA on a general basis, with the Agency stating as follows: "In response to the Coronavirus Disease 2019 (COVID-19) public health emergency, FDA's Center for Biologics Evaluation and Research (CBER) has taken steps to prioritize work that advances the nation's response during this national emergency."