[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA withdrew 47 guidance documents in early May after regulators declared them “unfinished and outdated.” The notice of the withdrawal was published in an early May Federal Register. The guidances that were withdrawn were incomplete or had been put on hold, during which time new scientific developments or shifts in regulatory policy rendered them irrelevant. A full list of the withdrawn guidance documents may be found on FDA’s website. Included in the withdrawn guidances were one on validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products and another on general considerations for providing regulatory submissions in electronic format.