Docket Number: FDA-2000-D-0074 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]

Docket Number: FDA-2010-D-0589 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research [updated: 6/24/2020] The purpose of this guidance is to assist sponsors and […]

Docket Number: FDA-1996-D-0004 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research […]

Docket Number: FDA-2011-D-0082 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research […]

Image Español Flu viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated in the fall can lower your chances […]

Docket Number: FDA-2021-D-1096 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-2004-D-0121 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This document provides guidance to industry […]

Docket Number: FDA-2011-D-0057 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes best practices pertaining […]

Image Español Women who are pregnant or breastfeeding often need to take prescription medications. The use of prescription medication during pregnancy and while breastfeeding has increased […]