This draft guidance describes FDA's current thinking on determining whether to submit an Abbreviated New Drug Application (ANDA) under section 505(j) of the FD&C Act or a 505(b)(2) application, including criteria for choosing between the two pathways and how to seek FDA's assistance. This revised draft updates and supersedes the... The post Determining Whether To Submit an ANDA or a 505(b)(2) Application appeared first on Avance Biosciences .