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Group Pens Open Letter to Hamburg on Vascepa Protocol Change

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The EPA Drug Initiative pens an open letter to FDA commissioner Margaret Hamburg asking her to intervene and reverse a recent CDER...

Social Media Posts Should Include Risk Info

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A recent blog post says companies should not give drug product information in social media without including the drugs pertinent r...

FDA Proposes to Improve Veterinary Feed Directive Program

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Federal Register Proposed rule: FDA proposes to amend its animal drug regulations on veterinary feed directive drugs to improve th...

FDA Warns Burzynski About Research Violations

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FDA warns Burzynski Research Institute about its failure to follow clinical research requirements and protect human subjects.

FDA Says No Clinical Support for Nipple Aspirate

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FDA tells consumers not to rely on needle aspirate tests as a standalone tool to detect breast cancer.

Guidance on Animal Drugs in Feed and Antimicrobial Use

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Federal Register Notice: FDA releases a guidance on revising conditions of use of new animal drugs administered in feed and to ali...

FDA Presents Device Review Assessment

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Federal Register Notice: FDA reveals high priority recommendations from an independent assessment of the device review process.

Nuvilex Plans Late-Phase Clinical Trials in Pancreatic Cancer

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Nuvilex plans a late-phase clinical trial comparing its investigational treatment with gemcitabine in patients with advanced, inop...

Drug Makers with Advanced Facilities See Fewer Inspections: Woodcock

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CDER director Janet Woodcock says FDA inspectors have shifted more focus to drug manufacturers that have operations that are antiq...

Sprout Appealing FDA Flibanserin Complete Response Letter

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Sprout Pharmaceuticals says it is using the FDA formal dispute resolution process to appeal the agencys complete response letter t...