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FDA Approves Hologic Aptima HPV Assay

[ Price : $8.95]

FDA approves a Hologic PMA for the Aptima HPV 16 18/45 genotype assay for use on the companys fully automated Panther system.

FDA Clears TiO2Mesh for Hernia Repair

[ Price : $8.95]

FDA clears a BioCer Entwicklungs 510(k) for its TiO2Mesh hernia repair system for repairing soft tissue defects in the abdominal w...

510(k) Benefit-Risk Determinations Guidance Top Priority

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A new CDRH Web site places developing a draft guidance on Benefit-Risk Determinations in Premarket Notifications (510(k)s) as one ...

FDA Will Allow Continued Iclusig Use Under Emergency IND

[ Price : $8.95]

FDA says healthcare professionals may continue to treat some patients with Iclusig under an emergency IND.

FDA Recommends Steps to Counter Heparin Risk

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FDA gives healthcare professionals timing recommendations for placing and removing spinal catheters in patients taking low molecul...

PhRMA, Genetic Alliance Working on Patient-focused Drugs

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PhRMA announces a joint program with the Genetic Alliance to use crowd-sourced technology to learn patients experiences with three...

RTI to Research Drug Ads for FDA

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FDA awards a $4 million contract to RTI International for five studies of various aspects of consumer response to DTC drug ads.

Moban Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Moban tablets and capsules were not withdrawn from sale for reasons of safety or effe...

Guidance on Developing Tuberculosis Drugs

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Federal Register Notice: FDA releases a guidance, Pulmonary Tuberculosis: Developing Drugs For Treatment.

Public Meeting on Sickle-Cell Disease

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Federal Register Notice: FDA plans a public meeting 2/7/14 on patient-focused drug development for sickle cell disease.