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ICH Coronavirus Coding

[ Price : $8.95]

The ICH says the Medical Dictionary for Regulatory Activities is being updated to standardize coding of the coronavirus.

Immunomedics FDA-483 Released

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FDA releases the FDA-483 with 10 inspection observations from an inspection of Immunomedics, Inc.

Vanda Phase 3 Study in Covid-19-related Pneumonia

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FDA gives Vanda Pharmaceuticals approval to begin a clinical study of tradipitant in hospitalized patients with Covid-19-related p...

FDA Reclassifying Hep C RNA Tests

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Federal Register notice: FDA proposes to reclassify nucleic acid-based hepatitis C virus ribonucleic acid devices intended for the...

3 QS Violations at Okamoto Rubber Products

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FDA warns Thailands Okamoto Rubber Products about QS violations in its manufacturing of lubricated natural rubber condoms.

QS Violations Found at E-Care Technology

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FDA warns Taiwans E-Care Technology about QS and MDR violations in its production of the Swiave thermometer.

Cellex EUA for Covid-19 Antibodies Test

[ Price : $8.95]

FDA grants an emergency use authorization to Cellex for a coronavirus serology test.

Giuliani-touted Therapy Wins IND Approval

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FDA approves a Rudy Giuliani-touted Celularity IND for its investigational stem cell therapy in Covid-19 patients.

Biocon FDA-483 Released

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FDA releases the FDA-483 with three observations issued following an inspection at Malaysias Biocon Sdn Bhd.

CGMP, Other Violations at Bulletproof 360

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FDA warns dietary supplement manufacturer Bulletproof 360 about CGMP and new and misbranded drug violations.