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Botanical review team

To implement the new Guidance, the CDER established a new Botanical Review Team (BRT) dedicated to the review of botanical specific issues in new drug applications (NDAs). A new Manual of Policies and Procedures... [Pg.319]

BOTANICAL REVIEW TEAM IN CENTER EOR DRUG EVALUATION AND RESEARCH... [Pg.322]

The CDER Botanical Review Team website http //www.fda.gov/cder/Offices/ ODE V BRT/default.htm provides links to many useful EDA Guidances and related documents, including the Botanical Guidance and MAPP. [Pg.326]

The BRT experts serve as members of the review teams, and provide scientific opinion on the botanical drug product in a role similar to that of other disciplines such as chemistry. [Pg.323]

See other pages where Botanical review team is mentioned: [Pg.228]    [Pg.228]    [Pg.323]    [Pg.323]    [Pg.131]    [Pg.92]    [Pg.78]   
See also in sourсe #XX -- [ Pg.319 , Pg.322 ]



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