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Act on Medical Dye Shortage: 30 GOP Representatives

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Some 30 GOP House members call on President Biden to take steps to alleviate a shortage of intravenous contrast agents.

FDA Updates Off-Patent, Off-Exclusivity List

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FDA publishes the latest update for its list of off-patent, off-exclusivity drugs for which there are no approved generics.

Guide on Quantitative Imaging Device Filings

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Federal Register notice: FDA makes available a final guidance entitled Technical Performance Assessment of Quantitative Imaging in...

Central Admixture Pharmacy FDA-483

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FDA releases the FDA-483 with six observations from an inspection at Phoenix, AZ-based Central Admixture Pharmacy Services.

Merck Keytruda sBLA for Non-small Cell Lung Cancer

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FDA accepts for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patien...

Stakeholders Seek Changes in CAR-T Draft Guidance

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Five stakeholders recommend changes and clarifications to an FDA draft guidance on CAR-T cell product development.

Gene Editing Stakeholder Comments

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Six stakeholders provide comments to FDA on the agencys docket on human gene therapy products incorporating human genome editing.

Researchers Confirm Increasing AI/ML Role in Drug Development

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CDER researchers describe the increasing use of artificial intelligence/machine learning in drug development regulatory submission...

CDER Caught Up on Domestic Pre-approval Inspections: Cavazzoni

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CDER director Patrizia Cavazzoni puts a positive spin on drug inspections, user fee goals, and enforcement and compliance activiti...

FDA Approves Rhythm Pharma sNDA for Imcivree

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FDA approves a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) injection, indicated for chronic weight manage...