Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability

• Date: December 16, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘PET Drugs—Current Good Manufacturing Practice (CGMP).’’ Elsewhere in this issue of the Federal Register, we are issuing final regulations on CGMPs for positron emission tomography (PET) drugs. We are issuing the guidance to help PET drug producers better understand FDA’s thinking concerning compliance with the PET CGMP regulations.

Click here to download the file