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Info Collection Extension on Formal Meetings Guide

[ Price : $8.95]

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...

Cipla Limited FDA-483

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FDA releases an FDA-483 with two observations from an inspection at Indias Cipla Limited.

Diabetes Cardiovascular Risk Guidance Committee Meeting

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FDA says a two-day meeting of the Endocrinologic and Metabolic Drugs Advisory Committee will consider changes that may be appropri...

Companies Weigh-in on Bendeka Exclusivity

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Several drug companies respond to FDAs request for comments on how to proceed with Bendeka orphan drug exclusivity in light of a c...

Regulatory Review Period Determined for Siliq

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Kirin-Amgens Siliq ...

Regulatory Review Period Determined for Tymlos

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Radius Healths Tyml...

Company Ordered to Stop Selling OTC Drug Products

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A federal judge enters a consent decree banning Tennessees Keystone Laboratories from marketing its OTC products until its facilit...