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Increase in Drug WLs Shows Structural Problem: Analysis

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Krieger Scientific CEO Joseph Morwald says a 59% increase in FDA drug Warning Letters in 2025 over 2024 should be seen by industry...

Hearing on FDA's Role in Retaining Biomedical Innovation in U.S.

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A Capitol Hill hearing next week examines how FDA can help strengthen the nation's leadership in biomedical innovation.

Petition Asks Committee Review of Anticholinergic Drugs

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Two former FDAers petition the agency to appoint an advisory committee to consider whether anticholinergic drugs are associated wi...

Restore Former Inspection Processes: Gortler

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Former FDAer David Gertler says its time for the agency to resume the unannounced, in-person inspections of drug and medical devic...

Catalent Indiana FDA-483 Out

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FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile dr...

Amphastar Subsidiary Gets Warning Letter for California Facility

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FDA sends Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at ...

Operation TrialBlazer May Reshape Clinical Development: Ropes & Gray

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A Ropes & Gray legal update examines FDA initiatives to shorten drug development timelines and reduce regulatory burdens for spons...

Mixed Stakeholder Views on Priority Voucher Pilot

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Four stakeholders express varying opinions on the future direction and existence of the FDA national priority drug voucher program...

BlephEx 12-Page Warning Letter

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FDA warns Brentwood, TN-based BlephEx about multiple violations in its manufacturing of three unapproved ophthalmic devices.

FDA Pauses Release of Complete Response Letters as it Mulls Policy

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FDA temporarily suspends its controversial practice of publicly releasing Complete Response Letters for rejected drug applications...