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4 Observations in SCA Pharmaceuticals FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Little Rock, AR-based SCA Pharmaceuticals outsourcing facility...

Keytruda Hits Endpoint in Cervical Cancer Trial

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Mercks Keytruda with concurrent chemoradiotherapy meets the progression-free survival primary endpoint in an interim analysis of t...

FDA Clears Xstrahl Skin Cancer Radiation Therapy

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FDA clears an Xstrahl 510(k) for its Radiant Aura treatment device for providing radiation therapy to non-melanoma skin cancer pat...

FDA Grants Fast Track for Myelofibrosis Drug

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FDA grants Karyopharm Therapeutics fast track status for selinexor for treating patients with myelofibrosis.

FDA Boosts Translational Sciences Achievements

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The CDER Office of Translational Sciences 2022 annual report lists what it says were achievements in five areas of activity.

Legislators Hit FDA's India, China Inspections

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Bipartisan leaders of the House Energy and Commerce Committee express concerns about FDA foreign inspections and ask for answers t...

Akebia Resubmitting Kidney Disease NDA

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Akebia Therapeutics completes an End of Dispute Type A meeting with FDA that discussed the companys upcoming NDA resubmission for ...

Medtronic Recalls Faulty Defibrillators

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Medtronic recalls its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with glassed fe...

Olympus Recalls Bronchoscopes Over Laser Compatibility

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Olympus recalls about 1,500 OES BronchoFiberscope BF Type devices after receiving complaints of endobronchial combustion during th...

Suggestions for Pediatric Drug Guidance

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Four drug stakeholders suggest changes to a draft FDA guidance on scientific considerations in pediatric drug development.