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PDUFA 7 Reauthorization Meeting Notes

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FDA releases summaries from three PDUFA 7 workgroup and subgroup discussions at the end of 2020.

FDA Should Do More in Covid Response: GAO

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The Government Accountability Office recommends additional things that FDA and other federal agencies should be doing as part of t...

Boston Scientific EMBLEM Electrode Recall is Class 1

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FDA says a Boston Scientific recall of EMBLEM defibrillator electrodes due to potential fracturing is Class 1.

FDA Clears Ventway Sparrow Ventilators

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FDA clears an Inovytec 510(k) to market its Ventway Sparrow ventilators in the U.S.

American Global Selling Unapproved AloeCure Products: FDA

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FDA warns American Global Health Group that it is marketing misbranded unapproved new drugs.

NeurMedix Cleared to Begin Phase 3 Alzheimers Trial

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FDA clears NeurMedix to begin a pivotal Phase 3 clinical trial to evaluate its lead (XXX DELETE XXX) drug candidate, NE3107 in Alz...

Complete Response Letter for Eagle Vasopressin ANDA

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Eagle Pharmaceuticals says it is responding to an FDA complete response letter for its vasopressin ANDA.

FDA Denies Public Citizen Seprafilm Petition

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FDA denies a Public Citizen petition asking it to rescind PMA approval for Genzymes Seprafilm but orders Warning and labeling chan...

Clinical Hold Lifted on Bubble Boy Therapy

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FDA lifts a clinical hold on Mustang Bios lentiviral gene therapy MB-107 and a pivotal Phase 2 clinical trial evaluating the poten...

Dont Approve Vasostrict Dosing Changes: Petition

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Attorney Scott Lassman petitions FDA to deny a Par Sterile Products sNDA seeking to modify dosing for Vasostrict based on patient ...