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Priority Review for Genentech Tecentriq sBLA

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FDA accepts for priority review a Genentech sBLA for a new indication for its Tecentriq.

Yates Memo Accountability Eased

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Attorney Anne Walsh outlines Justice Department changes to the Yates memo on individual accountability in criminal and civil cases...

FTC Supports FDA Deterring Petition Abuse

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The Federal Trade Commission says it shares FDA concerns about abuse of the citizen petition process to delay approval of generic ...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Barox Co., Globus Medical and MiBo Medical Group.

FDA Proposes De Novo Pathway Changes

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FDA issues a proposed rule to change the submission and review requirements for the medical device de novo classification pathway.

Regulatory Review Period for Aspire Assist Device

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Aspire Bariatrics medical d...

Regulatory Review Period for Synergys Trulance

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Synergy Pharmaceuticals Tru...

Regulatory Review Period for Intercepts Ocaliva

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FDA determines for patent extension purposes the regulatory review period for Intercept Pharmaceuticals Ocaliva (obeticholic acid)...

QS Issues at MiBo Medical Group

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FDA warns MiBo Medical Group about Quality System violations in its manufacturing of the MiBo Thermoflo.

CGMP Violations in Barox Inspection

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FDA warns Koreas Barox about CGMP violations in its production of finished drugs.