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, […]

Docket Number: FDA-2006-D-0464 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical […]

Docket Number: FDA-2018-D-0719 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research OMB Control Number: 0910-0014Expiration Date: 09/30/2026 […]

Docket Number: FDA-2021-D-1041 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

Docket Number: FDA-1993-D-0128 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research It is important to harmonize the way to gather and, if necessary, to […]

Docket Number: FDA-2008-D-0592 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes for industry the […]

Docket Number: FDA-2016-D-3561 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Devices and Radiological Health Office of the Commissioner, Office of […]

Docket Number: FDA-2017-D-6569 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research Center for Drug Evaluation and Research […]

Docket Number: FDA-2010-D-0026 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors of investigational new drugs and […]