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 […]

Docket Number: FDA-2021-D-0548 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The 21st Century Cures Act, signed […]

Docket Number: FDA-2000-D-0274 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance was developed to help […]

Docket Number: FDA-1999-D-0063 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to sponsors […]

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 […]