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January 3, 2023

globalpharmacyplus.com – 631427 – 12/27/2022

Product: Drugs Recipient: globalpharmacyplus.com Canada Issuing Office: United States FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded […]
January 3, 2023

Superior Glove Works, Ltd. – 641100 – 12/16/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Tony Geng Recipient Title Owner and President Superior Glove Works, Ltd. Acton ON L7J 1S1Canada Issuing […]
January 3, 2023

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 […]
December 29, 2022

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 […]
December 29, 2022

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 […]
December 29, 2022

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 […]
December 29, 2022

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. […]
December 27, 2022

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 […]
December 27, 2022

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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