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Guidance on Tobacco Products Document Submission

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Federal Register Notice: FDA releases a revised draft guidance: Health Document Submission Requirements for Tobacco Products.

Guidance on Planning/Design of Multi-Regional Trials

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Federal Register Notice: FDA releases a draft guidance entitled E17 General Principles for Planning and Design of Multi-Regional C...

Blood Products Panel to Meet

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Federal Register Notice: FDA plans a meeting of the Blood Products Advisory Committee 11/17 to discuss topics such as iron deficie...

Board to Center for Toxicological Research to Meet

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Federal Register Notice: FDA plans a meeting of the Science Advisory Board to the National Center for Toxicological Research 11/1-...

FDA Removes Civil Money Penalties Info from Regs

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Federal Register Final rule: FDA removes from its regulations the maximum civil money penalties table in order to comply with the ...

Novo Nordisk Recalls 6 Lots of GlucaGen HypoKit

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Novo Nordisk recalls six batches of its GlucaGen HypoKit due to two customer complaints involving detached needles on the syringe ...

Jazz Pharma Petitions FDA on Generic Xyrem Concerns

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A Jazz Pharmaceuticals citizen petition asks FDA not to approve any generic applications that reference its Xyrem (sodium oxybate)...

Emmaus Files NDA for Sickle Cell Drug

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Emmaus Life Sciences files an NDA for its orally administered pharmaceutical grade L-glutamine (PGLG) for treating sickle cell dis...

FDA Clears Carestream 3D Extremity Scan System

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FDA clears a Carestream 510(k) for the OnSight 3D Extremity System, which uses cone beam computed tomography technology to capture...

United Exchange Recalls Contaminated Eye Wash

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United Exchange Corp. recalls five lots of its Family Care Eye Wash due to microbial contamination.