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FDA Reports Shortages with Bleomycin

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FDA says manufacturing delays have caused a shortage with cancer therapy bleomycin for injection.

Patient Information Prototypes Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on an experimental study of patient information prototypes...

Info on Rapid Response Surveys Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on generic FDA rapid response surveys to the Office of M...

Info on Citizen Petitions, Stays of Action Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on citizen petitions and petitions for stay of action to t...

Info on IRBs Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on institutional review boards to the Office of Management...

Info on Health Notification Survey Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on the FDA Public Health Notification Readership Survey to...

Ortho Updates Ph Ranges on Immune Globulin

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Ortho Clinical Diagnostics updates the labeling of its Rho(D) Immune Globulin (Human) RhoGAM and MICRhоGAM Ultra-Filtered Pl...

FDA Accepts Pain Drug for Review

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FDA accepts for review a Pacira Pharmaceuticals NDA for Exparel (bupivacaine), a long-acting drug for postsurgical pain management...

Vivus Responds to FDA Qnexa Letter

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Vivus says it has responded to points raised in an FDA complete response letter on its obesity drug Onexa.

BioCheck Marketing Products for Unapproved Use: FDA

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FDAs San Francisco District Office warns BioCheck it is selling in vitro reagents for unapproved uses.