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Amgen Reports Positive Trial Data with Melanoma Therapy

[ Price : $8.95]

Amgen reports positive results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected Stage ...

Like the Phoenix, Pay-for Device Inspections Rise from the Ashes?

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Former FDA district director John Scharmann says CDRHs plan to pilot pay-for third-party inspections in January is likely to be as...

Vertex sNDA for Kalydeco Expanded Indication

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Vertex Pharmaceuticals files a supplemental NDA for Kalydeco (ivacaftor) monotherapy for people with cystic fibrosis aged six and ...

CDER Guidance on ANDA Refuse-to-Receive Criteria

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CDER releases a draft guidance on ANDA Submissions ― Refuse-to-Receive Standards that describes what should be included in a...

FDA to Retain 8,000 (55%) of its Staff Under Shutdown Plan

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Absent some miraculous compromise on Capitol Hill, it appears a government shutdown affecting almost half of FDA personnel is like...

FDA Accelerated Approval for Genentechs Perjeta

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FDA grants accelerated approval to Genentech for Perjeta (pertuzumab) and its use as part of a complete treatment regimen for pati...

CDRH Denies Petition Seeking Philips Device Recalls

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CDRH denies a 2009 citizen petition from a private individual to force a recall of all Philips medical devices affected by Philips...

FDA Approves Brintellix for Depression

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FDA approves a Takeda Pharmaceuticals and Lundbeck NDA for Brintellix (vortioxetine), indicated for treating adults with major dep...

House Passes Drug Compounding Bill

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The House of Representatives passes by a voice vote H.R. 3204, the Drug Quality and Security Act, which seeks to improve drug safe...

Medtronic Hit with Warning Letter as Part of MiniMed Approval

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FDA approves a Medtronic PMA for its MiniMed 530G artificial pancreas system along with a Warning Letter seeking manufacturing cor...