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Greater Transparency Could Bring FDA Trouble: DSOB Head

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Drug Safety Oversight Board executive director Steven Osborne tells reporters that greater transparency in board meeting summaries...

Menthol Report Subcommittee to Meet

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Federal Register Notice: FDAs Menthol Report Subcommittee will meet 9/27 to discuss the timelines and structure of the report on t...

FDA Says Celsions HEAT Study is Fast-Track

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FDA says Celsions Phase 3 HEAT study of ThermoDox and radiofrequency ablation in primary liver cancer patients is a fast-track dev...

CGMP Problems Found at Albany Molecular Research

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FDAs New England District Office warns Albany Molecular Research about CGMP problems at its Burlington, MA, drug manufacturing fac...

Consumers Concerned by Industry Influence Over Docs

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Consumers Union says many Americans who take prescription drugs are concerned that drug companies have too great an influence over...

Prolor Gains FDA OK for Growth Hormone Trial

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FDA gives Prolor Biotech regulatory approval to conduct a Phase 2 clinical trial in the U.S. using its longer-acting version of hu...

MedWatch Notice on Inomax Class 1 Recall

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An FDA MedWatch notice advises healthcare providers about a Class 1 recall involving Ikaria's vasodilator Inomax (nitric oxide).

FDA Changes Mesalamine ANDA Requirements

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FDA grants in part and denies in part two citizen petitions on bioequivalence requirements for generic forms of mesalamine product...

CDRH Guidance on BPH Trial Designs

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A new CDRH guidance identifies key features of non‐clinical and clinical investigational plans used to support IDEs, PMAs, a...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Albany Molecular Research, Blountys, DePuy Orthopedics, Herman Jenkins, Molteno ...