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2026 Warning Letter Trends Analyzed by Attorney

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Attorney Megan Robertsons analysis of 2026 FDA Warning Letters shows that CDER has been the most active Center, going after telehe...

4 Observations in Behring German Facility Inspection

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FDA releases the form FDA-483 issued following a 2026 inspection at the CSL Behring biological drug manufacturing facility in Marb...

FDA Cites Cliantha Research on Data Integrity, Quality Unit

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FDA investigators cite contract research organization Cliantha Research over data integrity, documentation and clinical research d...

Petition Urges FDA to Create Pathway for Brain-Computer Interfaces

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A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand huma...

FDA May Go Months Without Senate-Confirmed Commissioner: Analysis

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An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hu...

Diamantas Touts FDA Moves to Boost U.S. Jobs

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FDA acting commissioner Kyle Diamantas uses a Fox News editorial to tout agency steps he says are providing new jobs for American ...

FDA Selects Dexcom as First Participant in Digital Health Pilot with CMS

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FDA names Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pil...

FDA Plan Would Fundamentally Reshape Drug Ads

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Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consume...

FDA, Industry Have MDUFA 6 Agreement in Principle

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Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all...

FDA Approves GSK's Jideytro for ROS1-Positive Lung Cancer

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FDA approves GSK's Jideytro (zidesamtinib) for certain adults with locally advanced or metastatic ROS1-positive non-small cell lun...