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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...

FDA Targets Global Web Sites for Illegal Drugs

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FDA says that during the recent International Internet Week of Action it targeted 465 Web sites that illegally sold potentially da...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Auro Pharmacies.

Safety Alert on Raindrop Near Vision Inlay

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A new safety alert warns against an increased risk of corneal haze associated with Optics Medicals Raindrop Near Vision Inlay.

Review Extended for sBLA for Opdivo/Yervoy

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FDA extends by three months its review of a Bristol-Myers Squibb supplemental BLA for an indication in metastatic first-line non-s...