Summary Company Announcement Date: January 31, 2025 FDA Publish Date: January 31, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description There is potential that […]

Docket Number: FDA-2019-D-4247 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance (Guidance 2) is the second in a series of four […]

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 […]