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FDA Not Meeting PDUFA Dates on 2 Pfizer NDAs

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FDA says it will not meet the already-extended PDUFA action dates for Pfizer submissions for abrocitinib and Xeljanz.

FDA Seeking New Patient Engagement Collaborative Members

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FDA says it is soliciting applications for new Patient Engagement Collaborative members.

Keytruda/Lenvima Combo Gains Full Approval

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FDA grants full approval to the combination of Mercks Keytruda and Eisais Lenvima for treating certain patients with advanced endo...

Public Still Trusts FDA, CDC, Fauci: Survey

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An Annenberg Public Policy Center poll shows that the degree of confidence in FDA respondents have varies with their primary sourc...

Flexibility, Engagement are Covid Lessons for CDRH: Shuren

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CDRH director Jeff Shuren says two important lessons learned during the Covid-19 emergency that CDRH envisions continuing long aft...

Regen Centers Marketing Unapproved Cellular Products: FDA

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An FDA Notice of Violation says The Regen Centers is marketing unapproved cellular products and exosomes.

House Committee Wants FDA Drug Inspection Info

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The House Energy and Commerce Committee asks FDA acting commissioner Janet Woodcock what the agency intends to do about delayed dr...

Field Alert Report Guidance

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FDA issues a finalized question-and-answer guidance on submitting field alert reports.

FDA Clinical Hold on Magenta Trial

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FDA places a clinical hold on a Magenta Therapeutics Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia ...

Vero Biotech Recalls Nitric Oxide System

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Vero Biotech recalls its Genosyl DS; Nitric Oxide Delivery System due to a software issue that leads to errors in gas delivery.