Docket Number: FDA-2023-D-1909 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-2014-D-1411 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-2019-D-0362 Issued by: Guidance Issuing Office Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center […]

Docket Number: FDA-2021-D-0958 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to help small entities better understand the final […]

Docket Number: FDA-2018-D-2326 Issued by: Guidance Issuing Office Office of Inspections and Investigations Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This […]

Docket Number: FDA-2014-D-0609 Issued by: Guidance Issuing Office Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This […]

Docket Number: FDA-2018-D-0787 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical […]

Docket Number: FDA-2019-D-5743 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Office of Inspections and Investigations Office […]