Issued by: Guidance Issuing Office Office of the Commissioner, Office of the Chief Medical Officer, Office of Clinical Policy The following is a compilation of answers […]

Docket Number: FDA-2022-D-0286 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance […]

Docket Number: FDA-2011-D-0694 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-2008-D-0386 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The development safety update report (DSUR) […]

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This document provides guidance to sponsors planning to file […]

Docket Number: FDA-2019-D-4964 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This document is intended to provide […]

Docket Number: FDA-1998-D-0278 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The National Environmental Policy Act of […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-25-30 Product: Drugs Recipient: Recipient Name Mr. Arif Vazirally Recipient Title Executive Chairman […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Jason McGuire Recipient Title Senior Vice President, Operations Fagron Compounding Services, LLC dba Fagron Sterile Service […]