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Panel Votes to End Newborn Hepatitis B Shot Recommendation

[ Price : $8.95]

CDCs Advisory Committee on Immunization Practices votes to discontinue the longstanding policy that all newborns receive the Hepat...

FDA Advisers Reject J&Js V-Wave Heart Shunt

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An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients wi...

Device Compliance Official Flags Quality Gaps, Rising Enforcement

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A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medic...

Breyanzi OKd for Hard-to-Treat Marginal Zone Lymphoma

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FDA approves Juno Therapeutics CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal z...

Bayesian Statistical Analysis Demonstration Project

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FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.

CBER Inspections Challenged by Lack of Facility Readiness

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CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing f...

Clinical Hold Lifted on Vandas Motion Sickness Studies

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FDA lifts a partial clinical hold on one of Vanda Pharmaceuticals key tradipitant studies, clearing the company to expand dosing i...

Medical Device eCopy Submission Guidance

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FDA publishes a guidance on implementing the eCopy submission program for medical devices.

FDA, CMS Launching Tempo Pilot

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FDA launches a pilot with the Center for Medicare and Medicaid Innovation to promote access to certain digital health devices cove...

User Fees Could Incentivize U.S. Drug Development

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FDA reportedly is exploring ways PDUFA fees can be adjusted to incentivize companies to hold clinical trials in the U.S. rather th...