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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...

Praxis Epilepsy Drug Study Stopped for Positive Efficacy

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Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an ...

FDA 483 Cites Apotex Over Sterility, Data Integrity Failures

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FDA investigators issue a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotex...

Panel Votes to End Newborn Hepatitis B Shot Recommendation

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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...

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...

Quarter 3 Drug and Device Recalled Units Higher: Sedgwick Index

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The Sedgwick third-quarter recall index sees a sharp increase in the number of affected drug and medical device units.