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MDUFA Performance Goals, Procedures for 2028-2032

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FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027 renewal of MDUFA that will co...

FDA Plans Rule to Require Full Risk Info in Drug Ads

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FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, rad...

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.