Fda Reference Standard Guidance. In house primary reference standard. The federal register notice announcing the document s availability states this guidance is intended to address this confusion by explaining what these terms mean and by clarifying the differences among them.
The federal register notice announcing the document s availability states this guidance is intended to address this confusion by explaining what these terms mean and by clarifying the differences among them. This guidance provides recommendations on how applicants can accurately use these terms in an anda how persons can request fda designation of an rld and how persons can request fda selection of a reference standard. However there may be circumstances e g when the rld is no longer marketed in which the reference standard is a drug product other.
For purposes of this guidance and as set forth in circular a 119 the term standard or technical standard includes all of the following.
1 obtained from an officially recognized source 2 prepared by independent synthesis 3 obtained from existing production material of high purity or 4 prepared by further purification of. After fda has decided to recognize a standard we. The food and drug administration. The federal register notice announcing the document s availability states this guidance is intended to address this confusion by explaining what these terms mean and by clarifying the differences among them.
