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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.

Prasad Defends Vaccine Policy Shift: Report

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CBER director Vinay Prasad addresses a 12/4 investor conference in New York and defends his leadership, and attributing criticism ...

CDER Compliance Chief Details Compliance Shifts

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CDER Office of Compliance director Jill Furman highlights a year of sweeping operational shifts, heightened enforcement, and emerg...

Biden Admin Buried Covid Myocarditis Data: Makary

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FDA commissioner Marty Makary alleges that the Biden administration failed to disclose internal data on myocarditis risks in young...