FDA to Approve ANDAs on the Basis of Draft
The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling.
The guidance, which FDA is implementing without prior public comment because the agency says it””s a “less burdensome policy that is consistent with public health,” clarifies that the Office of Generic Drugs (OGD) will no longer require the submission of final printed labeling (FPL) in order to approve an ANDA.
See more at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM465628.pdf
