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Guide on Clinical Pharmacology Drug Labeling

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FDA releases a guidance on the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products Cont...

Biostage Granted Orphan Status for Esophagus Cell Regenerator

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FDA grants Biostage an orphan drug designation for Cellspan Esophageal Implant to restore the structure and function of the esopha...

Regulatory Review Period Established for Pfizers Trumenba

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Federal Register Notice: FDA determines the regulatory review period for Pfizers meningitis B vaccine Trumenba for patent term ext...

FDA Clears Nanowear SimplECG Device

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FDA clears a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment.

Draft Guide on Pharmacokinetic Analyses Format and Content

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Federal Register Notice: FDA posts a draft guidance on Physiologically Based Pharmacokinetic Analyses Format and Content.

Draft Guidance on Pharmacokinetic Analyses Format/Content

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FDA releases a draft guidance on Physiologically Based Pharmacokinetic Analyses Format and Content that outlines the recommended ...

Fast Track for Staph Aureus Pneumonia Therapy

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FDA grants Arsanis fast track status for ASN100 for preventing Staphylococcus aureus pneumonia in mechanically ventilated patients...

Stem Cell Anecdotal Claims Worrisome: Califf

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FDA commissioner Robert Califf says that approval of stem-cell therapies should be based on scientific evidence.

Medtronic Recalls Neurovascular Products

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FDA says Medtronic has recalled four neurovascular products due to the risk of coating separation and detachment.

Cures Act Promises FDA $500 mil. More, Heads to Senate

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After a 392-26 passage in the House, the 21st Century Cures Act heads to the Senate and could see a vote as early as next week.