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January 3, 2023
Published by Med Search on January 3, 2023
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July – September 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only, manufactured by ALK-Abelló, Inc. Certain product lots were associated with increased reports of false negative […]
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December 29, 2022
Published by Med Search on December 29, 2022
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E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers

Docket Number: FDA-2012-D-0315 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The ICH guidance E2C(R2) Periodic Benefit-Risk […]
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December 29, 2022
Published by Med Search on December 29, 2022
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E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)

Docket Number: FDA-2012-D-0315 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance defines the recommended format […]
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December 29, 2022
Published by Med Search on December 29, 2022
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Dr. Reddy’s Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

Summary Company Announcement Date: March 26, 2020 FDA Publish Date: March 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Ampules breaking & shattering […]
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December 29, 2022
Published by Med Search on December 29, 2022
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Division of Applied Regulatory Science

What we do The Division of Applied Regulatory Science (DARS) moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions. […]
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December 27, 2022
Published by Med Search on December 27, 2022
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UPDATED AGENDA INFORMATION: October 28, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 10/28/2022

On This Page Date: October 28, 2022 Time: 10:00 AM – 3:00 PM ET UPDATED INFORMATION (as of 10/13/2022): The meeting agenda has been updated to […]
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December 27, 2022
Published by Med Search on December 27, 2022
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Data Integrity and Compliance With Drug CGMP: Questions and Answers

Docket Number: FDA-2018-D-3984 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research, Office of […]
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December 27, 2022
Published by Med Search on December 27, 2022
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GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination

Summary Company Announcement Date: December 23, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is contaminated with […]
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December 27, 2022
Published by Med Search on December 27, 2022
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Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates

Summary Company Announcement Date: December 22, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Visible Glass […]
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