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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...

FDA Can Improve Medical Device Submission Process: Study

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Consultants Booz Allen Hamilton recommend four steps FDA could take to improve the medical device submission review process under ...

CDRH, ORA Compliance Improvement Pilot Program

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Additionally, FDA says it will expedite export certificate requests and prioritize device and pre-amendment determination requests...

FDA Panel Backs Stallergenes Allergy Drug

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FDAs Allergenic Products Advisory Committee votes 9 to 1 that available data support approval of a BLA for Oralair, indicated for ...

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 Still Has Dapagliflozin Questions

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FDA medical reviewers say they cant be certain from updated study information that Bristol-Myers Squibbs diabetes drug dapaglifloz...