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FDA Guide on Neurological Devices Targeting Disease Progression

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FDA posts a guidance on Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Dis...

Documents Show How Contentious Woodcocks Exondys Decision Was

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New CDER review documents embedded in a just-released approval package for Sareptas controversial Duchenne drug Exondys 51 (etepli...

Lawmakers Call for Probe on Drug Pricing Collusion

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Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) ask the Justice Department and the Federal Trade Commission to investig...

New CDRH Program to Leverage Patient Perspectives

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CDRH introduces a new program on the Patient and Care-partner Connection to allow patients and their organizations to dialog with ...

Lupin Says it Corrected GMP Issues at Indian Drug Plant

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Lupin says it has resolved GMP deficiencies cited by FDA during an inspection in March at its Goa, India manufacturing plant.

FDA Orphan Status for AbbVie Lung Cancer Drug

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FDA grants AbbVie an Orphan Drug Designation for veliparib, an oral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibito...

Dont Cave on Off-label Speech: Professors to FDA

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Law school professor Christopher Robertson and medical school professor Aaron Kesselheim urge FDA to continue to stand on principl...

Oxtellar Opinion Leader Video Misbrands Drug: OPDP

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CDERs Office of Prescription Drug Promotion notifies Supernus Pharmaceuticals that a Spanish-language video for its Oxtellar XR mi...

Committee to Look at Risk Communication Plan

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The FDA Risk Communication Advisory Committee will consider and comment on the agencys strategic plan for risk communication and h...

Aurinia Pharma Moves Into Phase 3 with Lupus Drug

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Aurinia Pharmaceuticals receives positive FDA feedback to plan a single Phase 3 clinical trial for voclosporin and its use in trea...