Today, the FDA issued 44 new and 37 revised draft product specific guidances (PSGs) outlining FDA's current thinking on the requirements for establishing bioequivalence to reference listed drugs or reference standards. None of the guidance documents were finalized in the current listings. According to the FDA Email, the 81 guidance documents included (and yes, I [...]The post Series of New and Revised PSGs Issued Today appeared first on Lachman Consultant Services, Inc..