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Dont License Mesoblasts Ryoncil: Petition

[ Price : $8.95]

A Lassman Law & Policy petition asks FDA to require substantial evidence of effectiveness before approving a BLA for Mesoblasts Ry...

Positive CDER Response to Liver Safety Biomarker

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CDER accepts a C-Path qualification plan for glutamate dehydrogenase as a safety biomarker for drug-induced liver injury.

Questions on FDA Response to Antibody Scams

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Four House Energy and Commerce Committee Democrats ask FDA for information on its response to fraudulent Covid-19 antibody test sc...

Draft Guide on Cannabis and Cannabis-Derived Compounds

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Federal Register notice: FDA makes available a draft guidance on quality considerations for cannabis and cannabis-derived compound...

FDA Backs Bioinformatics Computations/Analyses Standard

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Federal Register notice: FDA announces its support for use in regulatory submissions of the current version of an international st...

Congresspeople Question Drug Dog Tests

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Some 18 members of Congress ask FDA to report on its regulatory requirements and recommendations for testing drugs on dogs.

Cancer Patients Have Greater Covid Risk: OCE Analysis

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The FDA Oncology Center of Excellence says its analysis of real-world data shows that cancer patients with Covid-19 are at greater...

Integra LifeSciences Ultrasonic Surgical Device Cleared

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FDA clears an Integra LifeSciences 510(k) for its Cusa Clarity Ultrasonic Surgical Aspirator System for use in neurosurgery for re...

BD Expanded HPV Assay Approved

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FDA approves a Becton, Dickinson PMA supplement for an expanded version of its BD Onclarity Human Papillomavirus (HPV) Assay.

FDA Preparing for Combined Flu/Covid-19 Tests This Fall

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FDA commissioner Stephen Hahn says the agency is evaluating several different tests that can simultaneously test for both the flu ...