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Comments Sought on Symbols on IVD Labels

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Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection related to a recommended glos...

Regulatory Review Period for Novo Nordisks Tresiba

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Federal Register Notice: FDA determines the regulatory review period for Novo Nordisks diabetes therapy Tresiba (insulin degludec ...

CVM Revises Extralabel Use Guide for Medicated Feed

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FDAs Center for Veterinary Medicine (CVM) issues a revised compliance policy guide, effective immediately, on the extralabel use o...

Jury Awards $1 Billion on Hip Implant Case

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A federal jury in Dallas returns a combined verdict of more than $1 billion on behalf of six people who suffered serious medical c...

FDA Approves Lillys Jardiance to Reduce CV Death

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FDA approves a new indication for Eli Lillys Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patient...

FDA Steps to Improve Combination Product Review

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FDA steps up its focus on combination products and plans to finalize its guidance on human factors and GMPs this coming year.

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.