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Overdose Crisis Gets Priority in CDER Report

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CDER director Patrizia Cavazzoni says the 2023 Drug Safety Priorities report focuses on the nations drug overdose crisis.

PhRMA Seeks More FDA Info on Rare Disease Steps

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Pharmaceutical Research and Manufacturers of America asks FDA to take some specific follow-up steps to its virtual meeting on adva...

FDA Outlines Biosimilar Educational Outreach

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FDA increases its educational outreach to decrease hesitancy with biosimilar usage.

Mesoblast Wins Orphan Status for Revascor

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FDA grants Mesoblast an orphan-drug designation for Revascor (rexlemestrocel-L) and its use in children with congenital heart cond...

FDA Late with Diversity Plan Guidance

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A Regulatory Affairs Professionals Society online post says FDA is several weeks late in delivering a congressionally mandated gui...

Professor Blasts FDA on Harmful Supplements

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Harvard Medical School professor Peter Cohen blasts FDA for a lack of sufficient action to remove harmful dietary supplements from...

FDA Denies Zydus Indomethacin Suppository Petition

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FDA denies a Zydus petition asking the action to take actions about the indomethacin suppository reference standard.

9 Observations in Eugia Pharma Inspection

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FDA releases the form FDA-483 with nine observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufactur...

Citius Pharma Refiles BLA for Lymphoma

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Citius Pharmaceuticals resubmits a BLA for Lymphir (denileukin diftitox) for treating patients with relapsed or refractory cutaneo...

FDA Approves Eicos Frostbite Drug

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Regarding safety, the most common side effects of Aurlumyn include headache, flushing, heart palpitations, fast heart rate, nausea...