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Info on Rapid Response Surveys Sent to OMB

[ Price : $8.95]

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 Clears Radiosurgery Component for Lung Cancer

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FDA clears an Accuray Inc. 510(k) for its Lung Optimized Treatment, a new component for the firm's CyberKnife VSI System for perfo...

Orion Mulls Lawsuit to Block Generic Comtan

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Orion Corp. considers a patent infringement suit against Mylan after being told the company has submitted an ANDA for a generic co...

Guidance on Co-Developing Two Combo Drugs

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Federal Register Notice: FDA releases a draft guidance on the co-development of two or more unmarketed investigational drugs for u...

New Offices Added to Tobacco Center

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Federal Register Notice: FDA adds two new offices to its Center for Tobacco Products.

FDA, Pfizer Faulted on Chantix Trials

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The investigative journalism Web site Fairwarning criticizes FDA and Pfizer for not initially testing Chantix on patients with men...