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Medical Devices

Spending Bill Reverses Some FDA Court Losses: Attorneys

Two Hyman, Phelps & McNamara attorneys say FDA succeeded in having Congress use the recent omnibus spending bill to allow it to ban some individual us...

Medical Devices

FDA Discusses 2 New Trilogy Ventilator Issues

FDA describes two new issues that have occurred in some reworked Philips Respironics Trilogy 100 and 200 ventilators.

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FDA General

FDA Needs More Global Help Against Crime: Hermsen

Retired FDA top cop Catherine Hermsen says there is a need to expand collaboration with regulators in other countries to combat international criminal...

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Human Drugs

Reactions to Aduhelm Report Blast FDA Closeness to Industry

Reactions to a Congressional report on FDAs 2021 controversial review and approval of Biogens Alzheimers drug Aduhelm sharply criticize the approval a...

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Human Drugs

CGMP Deviations at Brazils Nortec Quimica

FDA warns Brazils Nortec Quimica about CGMP deviations in its production of active pharmaceutical ingredients.

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Human Drugs

FDA States Plan B One-Step Does Not Cause an Abortion

FDA revises the Plan B One-Step information sheet to clarify the emergency contraceptive cannot be used to cause an abortion of an existing pregnancy.

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Human Drugs

Court Enters Consent Decree Against Oklahoma Compounder

An Oklahoma federal court issues a consent decree against the Qualgen drug compounding facility and two of its principals.

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FDA General

FDA Gets $226 Million Spending Boost in Budget Bill

President Biden signs into law FDAs fiscal year 2023 spending bill as part of the end-year omnibus legislation (HR 2617, Consolidated Appropriations A...

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Human Drugs

FDA Grants Ardelyx Xphozah Appeal

FDA grants Ardelyx appeal of a complete response letter for its Xphozah to treat adult patients with chronic kidney disease on dialysis with hyperphos...

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Federal Register

Latest Federal Register Notices

FDA Webview posts the Federal Register notices that published during our annual holiday break.