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Include Premenopausal Women in Breast Cancer Trials: FDA

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FDA issues a draft guidance recommending the inclusion of premenopausal women in breast cancer drug clinical trials.

FDA Warns Battelle About Decontamination System MDR Issues

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FDA warns Battelle that the medical device reporting procedure and processes it has in place under an EUA for its respirator decon...

Vaccine Makers Could be Forced to be Transparent: Marks

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CBER director Peter Marks says that if vaccine manufacturers are not sufficiently transparent, FDA has procedures such as a commis...

FDA Wins Trump versus Science

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FDAs win in getting the White House to back down on its threats to block a controversial Covid-19 guidance illustrates a victory f...

Recall 2 Acetazolamide Lots: University Petition

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The University of Kentucky asks FDA to recall two lots of acetazolamide after its tests show reduced levels of the active ingredie...

FDA Withdrawing Makena, Denies Petition

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FDA denies a Public Citizen petition on Amags Makena while starting the process to have the drug withdrawn because its confirmator...

Joint Advisory Panel to Review Pain Combo Drug

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Federal Register notice: FDA announces an 11/2 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and...

Committee Dems Hit Azar on LDT Approvals

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House Energy and Commerce Committee Democratic leaders blast HHS secretary Alex Azar for a grave error in pulling the review of la...

Eton Pharmaceuticals NDA for Liquid Topiramate

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Eton Pharmaceuticals files an NDA for topiramate oral solution as a monotherapy for treating certain seizures and preventing migra...

FDA Wins FOIA Ruling on Confidential Info Redactions

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FDA prevails in a Freedom of Information Act lawsuit that found the agency appropriately allowed company-directed redactions of co...