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FDA Approves Pediatric Use of Poisoning Drug

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FDA says it has approved Baxters Protopam Chloride for treating organophosphate pesticide and chemical poisoning in pediatric pati...

FDA Transcript of Potiga Panel Meeting Available

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FDA posts a transcript of its 8/11 Peripheral and Central Nervous System Drugs Advisory Committee meeting that voted unanimously t...

FDA Requiring New Gadolinium Warnings

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FDA says it is requiring that labeling for gadolinium-based MRI contrast agents contain warnings for nephrogenic systemic fibrosis...

Review Period Set for SyntheMeds Repel-CV

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Federal Register Notice: FDA determines the regulatory review period for SyntheMeds Repel-CV for the purpose of patent extension.

Guidance on Suicidality Assessment in Clinical Trials

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Federal Register Notice: FDA releases a draft guidance on assessing the occurrence of suicidality in clinical trials of drug and b...

FDA Posts More McNeil Inspection Reports

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FDA posts additional inspectional documents from earlier agency inspections at McNeil Consumer Health's troubled Fort Washington, ...

Brain Cancer Trial Data Promising

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Clinical trial data from an ImmunoCellular Therapeutics study involving ICT-107 in brain cancer patients shows that 37.6% of patie...

Merck Scraps Hot Flashes Drug

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Merck decides to discontinue developing MK-6913 for treating hot flashes after receiving disappointing clinical trial data.

FDA Codifies Ophthalmic Solution for Dogs

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Federal Register Final rule: FDA amends the animal drug regulations to codify the conditions of use of an approved NADA for gentam...