(a) A licensed manufacturer may ask the Food and Drug Administration to waive under this section any requirement that applies to the licensed manufacturer under §§600.80 and 600.81. A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain one of the following:
CFR 21-600.90-2014 history
2014CFR 21-600.90-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.90:Waivers.