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April 20, 2020

Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments

Docket Number: None found Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This document provides current specifications […]
April 20, 2020

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use

Docket Number: FDA-1994-D-0318 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research Office of Medical Products and Tobacco, […]
April 20, 2020

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility

Docket Number: FDA-1996-D-0168 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Implementation of ICH E2B(R3) The E2B(R3) […]
April 20, 2020

Providing Regulatory Submissions in Electronic Format — Standardized Study Data

Docket Number: FDA-2012-D-0097 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 20, 2020

International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A

Summary Company Announcement Date: January 10, 2018 FDA Publish Date: January 10, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Mislabeling Company […]
April 20, 2020

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial

Summary Company Announcement Date: January 08, 2018 FDA Publish Date: January 10, 2018 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Presence of Glass […]
April 20, 2020

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products Due to Lack of Sterility Assurance

Summary Company Announcement Date: December 26, 2017 FDA Publish Date: January 11, 2018 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Lack of Sterility […]
April 20, 2020

Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance

Summary Company Announcement Date: January 11, 2018 FDA Publish Date: January 11, 2018 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Lack of Sterility […]
April 20, 2020

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold

Summary Company Announcement Date: January 11, 2018 FDA Publish Date: January 25, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Presence […]
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