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FDA Sued Over Rejection of Supplement Ad Claims

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Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for Natural Health USA could chan...

Blood Donor Screening in an Ebola Outbreak

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FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in r...

Repeat CGMP Violations Seen in Excelvision Inspection

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FDA warns Excelvision about CGMP violations in the production of drugs at its facility in Annonay, France.

Genzyme Ireland Inspection Documents CGMP Issue

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FDA warns Genzyme Ireland about the failure of the firms quality control unit to ensure that drugs comply with CGMP requirements.

Abiomed Impella Heart Pump Recall is Class 1

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FDA says the Abiomed recall of certain Impella CP Sets with SmartAssist is Class 1.

Insulet Omnipod Pod Recall is Class 1: FDA

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FDA says an Insulet recall of specific lots of its Omnipod Pods is Class 1.

FDA Selects 7 PreCheck Pilot Participants

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FDA selects seven companies from 80 applications to participate in the agencys PreCheck Pilot Program to advance U.S. drug manufac...

Next-Generation Sequencing Data Submission Guidance

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FDA publishes a guidance on submitting next-generation sequencing data to CDERs Division of Antivirals.

FDA OKs Blood Cancer Drug Tregzi

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FDA approves Orca Biosystems Tregzi to improve chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers...

CGMP Issues at Indias Wizcure Pharmaa

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FDA warns Indias Wizcure Pharmaa about CGMP violations in its production of over-the-counter drugs.