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Quality System Violations in Jacobus FDA-483

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FDA releases the inspection observations from a March-April inspection at Jacobus Pharmaceuticals.

FDA Approves Glaxos New COPD Drug

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FDA approves a GlaxoSmithKline NDA for Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term...

FDA Approves Glaxos Anoro Ellipta to Treat COPD

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FDA approves GlaxoSmithKlines new combination COPD drug Anoro Ellipta.

Medication Guides Updated for 22 Drugs

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FDA lists 22 drugs for which Medication Guides have been updated.

FDA, EMA Sharing Generic Drug Bioequivalence Info

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FDA says it is working with the European Medicines Agency and five European countries on joint inspections of bioequivalence studi...

Ikaria Continues to Protest GeNO Orphan Drug Designation

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Ikaria files a third supplement to its petition asking that FDA revoke its orphan drug designation for GeNOs nitric oxide product....

OIG Says FDA Must Continue FDASIA Implementation

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The HHS Inspector General says FDA must continue on its three-year program to implement provisions of the 2012 FDA Safety and Inno...

GSK Radically Changes Drug Marketing

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GlaxoSmithKline announces significant changes to marketing practices, including not based sale representative compensation on the ...

FDA ADHD Drug Warning on Painful Erections

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FDA orders a new warning on certain attention deficit hyperactivity disorder drugs because in rare instances they cause prolonged ...

Authors Call for Major Changes in FDA Operations

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Harvard University researchers say FDAs methods of operations and funding should be radically overhauled to keep patients from bei...