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Tonix Changes Tonmya Phase 3 Study

[ Price : $8.95]

Tonix Pharmaceuticals says that after receiving input from FDA, it is changing elements of its Phase 3 study of its Tonmya PTSD tr...

Abernathy Overhauling FDA Tech Infrastructure: Politico

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FDA principal deputy commissioner Amy Abernathy says the agency is overhauling its technology infrastructure to be prepared to cop...

FDA Updates Essure Post-Market Activities

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FDA updates its online records on post-market activities and studies of Bayers withdrawn Essure birth control device.

Fagron Recalls Lets Gel Convenience Packs

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Fagron recalls its Lets Gel Kit Convenience Packs due to potential microbial contamination of non-sterile products.

Philips Recalls Forte Gamma Camera System

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Philips Medical Systems recalls (Class 1) the Forte Gamma Camera System due to a nonconforming material/component.

RedHill Bio Gains H. Pylori Approval

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FDA approves a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules for tr...

DiFusion Spinal Interbody Device Cleared

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FDA clears a DiFusion 510(k) for the Xiphos-ZF Spinal interbody device.

Latest Federal Register Notices

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FDA Review posts the Federal Register notice for the week ending 8/1/2019.

Hep D Virus Drug Development Guide

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Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis D Virus Infection: Developing Drugs for T...

Draft Guide on Generic Drug User Fees

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Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees under the Generic Drug User Fee Amendme...