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 […]

Docket Number: FDA-2015-D-3235 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This is one in a series […]