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Group Wants More Real-world Evidence Examples

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The RWE Alliance suggests that FDA increase communications with external stakeholders about concrete real-world evidence use cases...

FDA Limits Lilly, Regeneron Covid Therapies

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FDA revises Eli Lillys emergency use authorization for bamlanivimab and etesevimab and Regenerons emergency use authorization for ...

FDA Seeks Comments on Covid Guidances

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Federal Register notice: FDA announces recent guidance documents related to the Covid-19 public health emergency.

Draft Guide on 702(b) FDA Samples

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Federal Register notice: FDA makes available a draft guidance entitled Collecting and Providing 702(b) Portions of FDA Official Sa...

FDA Revokes 5 Covid Test EUAs

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Federal Register notice: FDA revokes the Emergency Use Authorizations for five Covid tests because they are no longer marketed, di...

Guide on Technical Specs for NASH Drug Data Sets

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FDA posts a revised guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhot...

Medtronic Recalls HawkOne Atherectomy System

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Medtronic recalls its HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward ...

FDA Lifts Hold on Kura Leukemia Trial

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FDA lifts a partial clinical hold on a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory ...

Pazdur Mulls Accelerated Approval International Harmonization

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FDA Oncology Center of Excellence director Richard Pazdur suggests changes to the agencys accelerated approval program, such as in...

Arch Oncology Orphan Status for Multiple Myeloma

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FDA grants Arch Oncology an orphan drug designation for AO-176 and its use in treating relapsed/refractory multiple myeloma.