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  • FDA Drugs RSS Feed

    CDERLearn Training and Education

    29 November 2022, 10:42 pm
    Continuing Education and Training opportunities for healthcare professionals, academia, students and consumers.

    GDUFA Paid Facilities List

    29 November 2022, 8:09 pm
    This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

    Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022

    29 November 2022, 8:07 pm
    Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the c

    What's New Related to Drugs

    29 November 2022, 7:43 pm
    Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

    Drugs@FDA Data Files

    29 November 2022, 7:41 pm
    Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

    User Fee Lists

    29 November 2022, 3:09 pm
    Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.

    Antimicrobial Resistance Information from FDA

    29 November 2022, 1:28 pm
    Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

    2019 Meeting Materials, Dermatologic and Ophthalmic Drugs Advisory Committee

    29 November 2022, 11:37 am
    2019 meeting materials for the Dermatologic and Ophthalmic Drugs Advisory Committee, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, and transcript

    Biosimilar Product Information

    28 November 2022, 8:34 pm
    This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

    FDA Food RSS Feed

    Fudgeamentals Recalls Chocolate Fudge Bites Because of Undeclared Walnuts

    17 November 2022, 6:32 pm
    Fudgeamentals of Melville, New York has voluntarily recalled one lot of Chocolate Fudge Bites packaged in 8 oz. plastic containers. The Chocolate Fudge Bites products may contain Chocolate Walnut Fudge Bites products instead, resulting in the presence of undeclared tree nut (walnut) ingredient. The

    J&M Foods Issues a Voluntary Recall on a Select Lot Number of Lavender Shortbread Cookies Due to the Packages Contain Chocolate Chip Cookies That Do Not Disclose the Correct Allergens

    30 June 2022, 5:19 pm
    Little Rock, Arkansas – J&M Foods is initiating a voluntary recall because a select number of the Lavender Shortbread Cookies were erroneously packed with Chocolate Chip Cookies. As a result, the packaging does not list the presence of a possible allergen (soy or eggs). Some people who have an ext