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Draft Guide on Hepatitis B Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis B Virus Infection: Developing Drugs for T...

Workshop on Hemophilia Product Development

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Federal Register notice: FDA announces a 12/6 public workshop entitled Product Development in Hemophilia.

FDA Approves Controversial Pain Drug

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FDA approves an AcelRx Pharmaceuticals resubmitted NDA for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moder...

2 Devices Cleared for Parathyroid Tissue Detection

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FDA permits the de novo marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures ...

Class 1 Recall for Roche CoaguCheck Test Strips

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FDA classifies as Class 1 a Roche Diagnostics recall of its CoaguChek XS PT Test Strips due to inaccurate International Normalized...

Hepatitis B Drug Development Guidance Out

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FDA issues a draft guidance to assist sponsors develop drugs and biologics to treat chronic hepatitis B viral infections.

FDA Warns About Some Genetic Test Predictions

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FDA warns against using results from many genetic tests to predict how a patient will respond to a specific medication.

Class 2 for Meprobamate Test System

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Federal Register notice: FDA classifies the meprobamate test system into Class 2 (special controls).

De Novo Marketing for Pharmacogenetic Reports

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FDA permits the de novo marketing of 23andMes Personal Genome Service Pharmacogenetic Reports as a direct-to-consumer test for pro...

Insulin Therapy Adjustment Devices into Class 2

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Federal Register notice: FDA classifies insulin therapy adjustment devices into Class 2 (special controls).