Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The process of implementing this section of FDAMA was logically divided into two stages. During […]

Docket Number: FDA-2012-D-1120 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations for the development of vaginal microbicides regulated within […]

Docket Number: FDA-1994-D-0134 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Guidelines for the testing of pharmaceuticals for genetic toxicity have been established […]

Docket Number: FDA-2004-D-0366 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance describes a nonclinical testing […]

Docket Number: FDA-2009-D-0528 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The ICH guidance E7 Studies in […]

Docket Number: FDA-2021-D-1146 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence The 21st […]

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice Center for […]

Docket Number: FDA-2002-D-0177 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This document provides recommendations for sponsors […]

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to clarify what preclinical and clinical approaches, as well as chemistry, […]