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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...

Smiths Medical Class 1 Recall of Syringe Pump

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Smiths Medical ASD recalls its Medfusion model 4000 syringe pump due to issues associated with earlier software versions.

Guidance on Charging for Investigational Drugs

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FDA posts a final guidance entitled Charging for Investigational Drugs Under an IND Questions and Answers.

Drug Regulatory Site Tours Continue

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Federal Register notice: FDA announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction...