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Joint Panel to Mull Increasing Naloxone in Communities

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Federal Register notice: FDA announces a 12/17 joint advisory committee meeting to discuss strategies to increase the availability...

2007 FDA Law Brought Better Trial Reporting: Study

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A new study concludes that the FDA Amendments Act (FDAAA) of 2007 has led to more clinical trials being registered and results bei...

Regulatory Review Period Determined for Lartruvo

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Imclones Lartruvo.

Testicular Toxicity Draft Guidance

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FDA publishes a draft guidance to assist sponsors who develop drug products that may result in testicular toxicity.

20 Years of FDA Innovation

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FDA deputy commissioner Anna Abram tells the JAX Healthcare Forum how innovation is part of FDAs DNA.

Regulatory Review Period Determined for Tecentriq

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Genentechs Tecentri...

Info Collection Extension on Formal Meetings Guide

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Federal Register notice: FDA submits to OMB an information collection extension for its guidance on Formal Meetings With Sponsors ...

Regulatory Review Period Determined for Besponsa

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Wyeths Besponsa (in...

Multiple Inspection Issues at Auro Pharmacies

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FDA warns Californias Auro Pharmacies about multiple violations in its drug compounding operations.

Naloxone Availability Advisory Committee Meeting

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FDA commissioner Scott Gottlieb says two advisory committees will discuss ways to make naloxone more readily available to combat o...