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Comments Sought on Postmarket Surveillance

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Federal Register Notice: FDA seeks comments on its postmarket surveillance regulations.

Advisory Committee Nominations Sought

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Federal Register Notice: FDA requests nominations for consumer representatives to serve on various advisory committee.

Draxxins Review Period is Set

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Federal Register Notice: FDA determines the regulatory review period for Pfizers Draxxin is 2,451 days.

Review Period Set for Natrecor

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Federal Register Notice: FDA determines the regulatory review period for Scios Natrecor for the purpose of patent extension.

FDA Approves 2 New Rituxan Indications

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FDA approves two expanded indications for Genentechs Rituxan for patients with CD20-positive, B-cell non-Hodgkin's lymphoma.

Reprocessed SUDs Like New, Schultz Says

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CDRH director Daniel Schultz tells Congress that correctly reprocessed single use devices are as safe and effective as new devices...

FDA Warns of Potential Lamictal Birth Defects

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FDA says GSKs Lamictal may cause cleft palate or cleft lip in babies whose mothers took the drug during the first trimester of pre...

Labopharm Once-Daily Tramadol is Approvable

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FDA issues Labopharm an approvable letter for a once-daily formulation of tramadol, marketed by other companies as immediate-relea...

Genentech on Avastin Data Has Tiger by the Tail

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Genentech creates a patient support-group furor over its refusal to release a complete response letter containing new FDA review d...

CDER Withdraws 3 Outdated Guidances

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Federal Register Notice: CDER withdraws three outdated guidances on electronic submissions.