#USFDA
Import of unapproved drug product is not permitted unde FDA's Food and Drugs Act. However, it is allowed in certain cases where the application/ product is is final stages of approval. To formalize this process USFDA has drafted guidance for the same.
This guidance is applicable for ANDA, NDA as well as BLA products. This approach is generally followed by companies for first to file products to get full advantage of 180 day exclusivity.
Take full advantage of exclusivity through PLAIR Guidance of USFDA #first-to-file
#ANDA
#usfda
#plair
#launch
#NPL