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FDA to Post Individual Consumer Comments

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Federal Register Notice: FDA plans to post comments submitted by individuals on the regulations.gov Web site.

FDA Grants Part of Pfizer Quillivant BE Petition

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FDA agrees with Pfizer on using partial area under the curve metrics as part of demonstrating bioequivalence to Quillivant.

2 New CDRH Learn Modules

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CDRH adds two modules to its CDRH Learn Web site of industry training programs.

FDA Clears Precision Spine Pedicle Screw

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FDA clears a Precision Spine 510(k) for the Reform Modular and HA (hydroxyapatite) Coated Pedicle Screw System.

PMA Approval for Cook Medical Endo Graft

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FDA approves a Cook Medical PMA for its lower-profile Zenith Alpha Thoracic Endovascular Graft, indicated for the endovascular tre...

Reprocessed Bronchoscopes Have Lower Risk: FDA

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FDA says the risk of infection transmission associated with reprocessed bronchoscopes appears to be lower than the risk presented ...

Can-Fite Bio Gains Fast Track for Liver Cancer Drug

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Can-Fite BioPharma has been granted an FDA fast track designation for CF102 and its use as a second line treatment for hepatocellu...

FDA OKs Allergan/Gedeon NDA for Vraylar

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FDA approves an Allergan and Gedeon Richter NDA for Vraylar (cariprazine) capsules, an atypical antipsychotic for acute treatment ...

Obama urged to Discuss Heparin with Chinese President

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House Energy and Commerce Committee leaders ask President Obama to discuss Chinas role in the 2007-08 contaminated heparin scare w...

FDA, TG Therapeutics Agree on SPA for Leukemia Trial

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FDA and TG Therapeutics agree on a Special Protocol Assessment on a Phase 3 clinical trial of its TG-1101 and TGR-1202 for treatin...